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A Phase III, randomized, two armed, parallel, double blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Cetuximab (produced by CinnaGen) and FOLFIRI compared with Erbitux® (Cetuximab, the reference drug, produced by Merck Company) and FOLFIRI as first-line treatment for RAS wild-type Metastatic Colorectal Cancer

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History
# Registration date Revision Id
4 2024-02-07, 1402/11/18 295115
3 2019-11-09, 1398/08/18 111503
2 2019-03-19, 1397/12/28 89749
1 2017-11-15, 1396/08/24 18716
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  • Protocol summary

    this is a Phase III, randomized, two armed, parallel, double blind (patient and assesor), active controlled, equivalency clinical trial, to compare the efficacy and safety of Cetuximab (produced by CinnaGen company) plus FOLFIRI and Erbitux® (Cetuximab, the reference drug, produced by Merck Company) plus FOLFIRI as first-line treatment for RAS wild-type Metastatic Colorectal Cancer. Patients diagnosed with RAS wild-type Metastatic Colorectal Cancer, according to RECIST criteria (Response Evaluation Criteria in Solid Tumors) and age of 18 years or older will be included. Patients with certain medical conditions such as previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy and those with adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial and patients that have been treated with radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial and also female patients who are pregnant or lactating and those with history of allergic reactions attributed to compounds chemically or biologically similar to cetuximab, irinotecan, 5-FU or leucovorin and patients with a history of another primary malignancy in less than 5 years, with the exception of non-melanoma skin cancer and carcinoma in-situ of uterine cervix and also those with inability to comply with study and/or follow-up procedures are excluded. This is a randomized, double blind clinical trial in which cetuximab is administered intravenously 400 mg/m2 for the first infusion then weekly intravenous infusions of 250 mg/m2, in addition to bi-weekly Irinotecan infusion of 180 mg/m2, Folinic Acid infusion of 400 mg/m2 (racemic) or 200 mg/m2 (L-form), 5-Fluorouracil bolus of 400 mg/m2 followed by a 46-hour continuous infusion of 2400 mg/m2 until progression or unacceptable toxicity develops for 156 patients in the Cetuximab group and 78 patients in Erbitux® group over 6 months. Changes from baseline in disease activity according to WHO criteria will be assessed in 26 weeks. The randomization plan of the patients will be carried out using an system (R-CRAN version 3.2.3). Using permuted block randomization blocks (length of each block is 2 or 4) will be made, for a total of 234 patients (with 2:1 allocation ratio).
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    این مطالعه یک کارآزمایی بالینی فاز 3، تصادفی سازی شده، موازی، دو سو کور (بیمار و ارزیابی کننده) با کنترل فعال جهت بررسی هم ارز بودن اثربخشی و ایمنی ستوکسیمب (تولید شرکت سیناژن) نسبت به Erbitux® (تولید شرکت Merck)، هنگام افزودن آن به رژیم FOLFIRI (ایرینوتکان به علاوه لوکوورین/5-فلوئورواوراسیل به صورت انفوزیون پیوسته) در بیماران مبتلا به سرطان کولورکتال متاستاتیک بدون جهش در ژن های RAS میباشد. بیماران با شاخص های ورود به مطالعه شامل: جنسیت مذکر یا مؤنث، سن بزرگتر از 18 سال، مبتلا به سرطان کولورکتال متاستاتیک (تأیید شده با histology)، داشتن یک (یا بیشتر) ضایعه قابل اندازه گیری از دو بعد (طبق تعریف کرایتریای RECIST)، کاندید نبودن برای برداشت کامل و درمان کننده ضایعه، با شاخص ECOG کوچکتر یا مساوی ، احتمال زنده بودن بیش از 3 ماه (با ارزیابی بالینی)،شواهد بیان EGFR (expanded wild-type RAS)، داشتن عملکرد مناسب ارگان ها و مغز استخوان با شرایط: شمار مطلق نوتروفیل بزرگتر مساوی /mm31500، شمار پلاکت بزرگتر مساوی /mm3100000، سطح هموگلوبین بزرگتر مساوی g/dl9 (ممکن است بیمار سابقه دریافت خون داشته باشد)، بیلی روبین تام کوچکتر مساوی 1.5 برابر حداکثر مقدار نرمال آزمایشگاه اندازه گیری کننده، سطح AST و ALT کوچکتر مساوی 2.5 برابر حداکثر مقدار نرمال آزمایشگاه اندازه گیری کننده یا 5 برابر حداکثر مقدار نرمال آزمایشگاه اندازه گیری کننده در موارد متاستاز کبدی شناخته شده، سرم کراتینین کوچکتر مساوی 1.5 برابر حداکثر مقدار نرمال آزمایشگاه اندازه گیری کننده، سطح INR کوچکتر مساوی 1.5 و PTT کوچکتر مساوی 1.5 برابر حداکثر مقدار نرمال آزمایشگاه اندازه گیری کننده و شاخص های عدم ورود شامل: سابقه درمان با داروهای anti-EGFR یا شیمی درمانی با پایه ایرینوتکان، رادیو تراپی، جراحی (به جز بیوپسی تشخیصی) و یا مصرف داروی تحقیقاتی کمتر از 30 روز قبل از ورود به مطالعه، خانم باردار و یا در حال شیردهی، بیماران با سابقه بدخیمی دیگر در 5 سال اخیر، به جز سرطان های پوست غیر ملانوما و کارسینومای غیرتهاجمی دهانه رحم، داشتن سابقه حساسیت مرتبط با ترکیبات با ساختار شیمیایی یا بیولوژیک مشابه با ستوکسیمب، ایرینوتکان، فلوئورواوراسیل و یا لوکوورین. سابقه دریافت درمان ادجوانت که 6 ماه یا کمتر از اتمام آن گذشته باشد. عدم توانایی در پیگیری و انجام فرایند های تحت مطالعه، وارد مطالعه می شوند و به طور تصادفی در یکی از گروه های درمانی قرار میگرند. در این مطالعه ستوکسیمب (ساخت شرکت سیناژن و یا ساخت شرکت Merck) به صورت انفوزیون اولیه mg/m2 400 در طول 120 دقیقه و سپس انفوزیون های بعدی mg/m2 250 در طول 60 دقیقه به صورت هفتگی تزریق می شود. رژیم FOLFIRI شامل داروی ایرینوتکان mg/m2 180 در طول 30-90 دقیقه، داروی لوکوورین mg/m2400 در طول 120 دقیقه،داروی 5-فلوئورواوراسیل mg/m2 400 بولوس و سپس mg/m2 2400 در طول 46 ساعت نیز هر دو هفته تزریق می گردد. 234 بیمار وارد مطالعه خواهند شد که 78 نفر در گروه دریافت کننده Erbitux® و 156 نفر در گروه دریافت کننده ستوکسیمب سیناژن برای مدت 6 ماه تحت مطالعه قرار می گیرند. تصادفی سازی بیماران توسط نرم افزار R-CRAN نسخه 3.2.3 به انجام می رسد. با استفاده از بلوک های جایگشت شده تصادفی، بلوک هایی (اندازه هر بلوک 2 یا 4 است) برای مجموع 234 بیمار (با نسبت 2:1) ساخته خواهد شد.
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    The aim of this study is to determine the equivalency of efficacy and safety of cetuximab (CinnaGen) versus Erbitux® (Merck) in progression free survival (PFS) when added to FOLFIRI (irinotecan plus leucovorin/ 5-fluorouracil continuous infusion) in patients with metastatic colorectal cancer (mCRC) without mutations in RAS genes
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    هدف از این مطالعه بررسی هم ارز بودن اثربخشی و ایمنی ستوکسیمب (تولید شرکت سیناژن) نسبت به Erbitux® (تولید شرکت Merck)، هنگام افزودن آن به رژیم FOLFIRI (ایرینوتکان به علاوه لوکوورین/5-فلوئورواوراسیل به صورت انفوزیون پیوسته) در بیماران مبتلا به سرطان کولورکتال متاستاتیک بدون جهش در ژن های RAS میباشد
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    A phase III, Active-controlled, Parallel, double-blind, randomized clinical trial
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    کارآزمایی بالینی فاز 3، دارای گروه کنترل فعال، با گروه های موازی، دو سویه کور، تصادفی شده
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    This is a multicenter, double-blinded study.
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    این یک مطالعه چندمرکزی است که در آن پزشک و بیماران اطلاعی از داروی دریافت شده ندارند.
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    Inclusion: • Age of 18 years or older • Histologically confirmed adenocarcinoma of the colon or rectum • Having one or more bi-dimensionally measurable lesions as defined by RECIST Criteria • Adequate organ and marrow function Exclusion: • Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy • Adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial • The use of radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial • Female patients who are pregnant or lactating chemically or biologically similar to Cetuximab, irinotecan, 5-FU or leucovorin. • Patients with a history of another primary malignancy in less than 5 years, • Inability to comply with study and/or follow-up procedures
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    بیماران با معیارهای ورود: بزرگتر از 18 سال، مبتلا به سرطان کولورکتال متاستاتیک دارای ضایعه قابل اندازه گیری از دو بعد و بدون جهش ژنی RAS، با پرفورمنس مناسب و عملکرد مناسب ارگان ها می تواند وارد مطالعه شود. همچنین خانم باردار و یا در حال شیردهی، افراد با سابقه درمان با داروهای anti-EGFR یا شیمی درمانی با پایه ایرینوتکان، رادیو تراپی، جراحی ماژور و یا مصرف داروی تحقیقاتی کمتر از 30 روز قبل از ورود به مطالعه، بیماران با سابقه بدخیمی دیگر در 5 سال اخیر، حساسیت مرتبط با ترکیبات رژیم مطالعه و سابقه دریافت درمان ادجوانت که 6 ماه یا کمتر از اتمام آن گذشته باشد و توانایی در پیگیری و انجام فرایند های تحت مطالعه را ندارند، نمی توانند وارد طرح شوند.
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    Cetuximab 400 mg/m2 for the first and 250 mg/m2 for subsequent doses
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    ستوکسیمب با دوز 400 mg/m2 در دوز اول و 250 mg/m2 در دوزهای بعدی
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    Primary Endpoint: Progression Free Survival Secondary Endpoints: Overall Survival, Time to Treatment Failure, Objective Response Rate, Safety, and Immunogenicity.
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    هدف اصلی: بقای بدون پیشرفت اهداف ثانویه: بقای کلی، زمان تا شکست درمان، پاسخ درمانی عینی، ایمنی و ایمونوژنیسیته

  • General information

    75
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    Year
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    No
    Yes
    1
    1
    1
    male or female
    Age of 18 years or older
    histologically confirmed adenocarcinoma of the colon or rectum
    having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
    metastatic disease that could not be resected for curative purposes
    immunohistochemical evidence of tumor EGFR expression (expanded wild-type RAS)
    Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
    life expectancy of longer than 3 months (by clinical assessment)
    adequate organ and marrow function.
    جنسیت مذکر یا مؤنث
    سن بزرگتر از 18 سال
    مبتلا به سرطان کولورکتال متاستاتیک (تأیید شده با histology)
    داشتن یک (یا بیشتر) ضایعه قابل اندازه گیری از دو بعد (طبق تعریف کرایتریای RECIST)
    کاندید نبودن برای برداشت کامل و درمان کننده ضایعه
    شواهد بیان EGFR (expanded wild-type RAS)
    شاخص ECOG کوچکتر یا مساوی 2
    احتمال زنده بودن بیش از 3 ماه (با ارزیابی بالینی)
    داشتن عملکرد مناسب ارگان ها و مغز استخوان
    Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy
    the use of radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial
    female patients who are pregnant or lactating
    patients with a history of another primary malignancy in less than 5 years, with the exception of non-melanoma skin cancer and carcinoma in-situ of uterine cervix
    patients with history of allergic reactions attributed to compounds chemically or biologically similar to Cetuximab, irinotecan, 5-FU or leucovorin
    adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial
    inability to comply with study and/or follow-up procedures
    Subjects with known infection with HIV, HBV, HCV
    سابقه درمان با داروهای anti-EGFR یا شیمی درمانی با پایه ایرینوتکان
    رادیو تراپی، جراحی (به جز بیوپسی تشخیصی) و یا مصرف داروی تحقیقاتی کمتر از 30 روز قبل از ورود به مطالعه،
    خانم باردار و یا در حال شیردهی
    بیماران با سابقه بدخیمی دیگر در 5 سال اخیر، به جز سرطان های پوست غیر ملانوما و کارسینومای غیرتهاجمی دهانه رحم
    داشتن سابقه حساسیت مرتبط با ترکیبات با ساختار شیمیایی یا بیولوژیک مشابه با ستوکسیمب، ایرینوتکان، فلوئورواوراسیل و یا لوکوورین.
    سابقه دریافت درمان ادجوانت که 6 ماه یا کمتر از اتمام آن گذشته باشد
    عدم توانایی در پیگیری و انجام فرایند های تحت مطالعه
    بیماران مبتلا به HIV، HCV و HBV
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    Eligible patients will be assigned to treatment with the use of a dynamic randomization algorithm that will be designed to achieve overall balance between groups; randomization will be stratified according to site of primary tumor and number of metastasis (1 or more than 1) with 1:2 allocation ratio. After randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the 2 first letter of the first name, the 2 first letter of the first surname) and 3 numbers (center code). Moreover, the code described is followed by study unique identification consisting of first three letters of the generic name (which is CET-) and 3 numbers (corresponding to the randomization number), e.g. ABCD001CET-001. The randomization number will be assigned in a consecutive way. concealment process: Randomization will not be exposed to those conducting the study and will be provided in sealed opaque envelopes with successive numbers. The original paper of randomized remains in the CRO Trial and after checking eligibility criteria, the randomization code is given to the prescriber by telephone. Randomization will not be exposed to the trial executers and will be provided to the researcher of each center in non-transparent sealed envelopes.
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    در این مطالعه یکی از روش های داینامیک (minimization) برای تخصیص بیماران به گروه های درمانی مورد استفاده قرار خواهد گرفت. در این نوع رندومیزیشن دو متغیر: تعداد سایت های متاستاتیک (1 و بیشتر از یکی) و محل تومور (راست و چپ) در تخصیص به گروه های درمانی در نظر گرفته می شود. زمانی که تصادفی سازی انجام شد هر بیمار کدی را دریافت می کند که توسط آن در طول مطالعه شناخته خواهد شد. کد اختصاص یافته به ترتیب از 4 حرف (متناظر با دو حرف اول نام و دو حرف اول نام خانوادگی)، سه عدد (کد مرکز)، سه حرف اول نام ژنریک دارو (که همانا CET- می باشد) و 3 رقم (متناظر با کد تصادفی سازی)، تشکیل می شود که همان کد بیمار خواهد بود. به طور مثال: ABCD001CET-001. اعداد تصادفی سازی به طور متوالی تعیین می شوند. هربسته دارویی ستوکسیمب برای دوره درمان یک بیمار طی مطالعه یک کد 3 رقمی مشابه کد تصادفی سازی خواهد داشت (این کد شامل دو حرف انگلیسی و یک عدد می باشد که برای هر بیماری این 3 کاراکتر منحصر به فرد است) بنابراین تا زمانیکه که کد تصادفی سازی منحصربه فرد است، هر بیمار نیز یک بسته دارویی منحصر به فرد خواهد داشت که کاملا با فرایند تصادفی سازی شده مشخص خواهد شد. مسئولیت ایجاد کد های تصادفی سازی بر عهده CRO مطالعه (CRO Trial به نمایندگی از دکتر حامد حسینی) است. فرآیند پنهان سازی گروه بندی بیماران: گروه بیماران و نوع داروی دریافتی آنان، به محققان فاش نخواهد شد. بعد از حصول اطمینان از واجد شرایط بودن بیمار و امضای فرم رضایت اگاهانه، با توجه به برگه اصلی تصادفی سازی کارآزمایی، بیماران در یک گروه خاص درمانی قرار می گیرد. (برگه اصلی تصادفی سازی کارازمایی در مرکز CRO Trial باقی می ماند و بعد از چک کردن معیارهای واجد شرایط بودن، کد تصادفی سازی به تجویز کننده، با تماس تلفنی اعلام می شود.) تصادفی سازی به مجریان مطالعه فاش نخواهد شد و در پاکت های مهر و موم شده غیر شفاف به محقق هر مرکز ارائه خواهد شد.
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    Both cetuximab products are indistinguishable for patients and health care providers. Since the route of administration is infusion, and the size and shape of the vial, cap, seal, aluminum and the color are quite similar, it is not possible to distinguish the type of brand from the appearance of vials and it will be possible to make patients blind about the treatment group which they have been allocated to
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    هر دو داروی ستوکسیمب مورد مطالعه برای بیماران و کادر درمانی مربوطه غیر قابل تشخیص بوده چرا که از نظر اندازه و شکل ویال، Cap ،seal آلمینیومی و رنگ کاملا مشابه هم هستند و نمیتوان نوع برند داروها را از ظاهر ویال ها تشخیص داد
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  • Secondary Ids

    #1
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    ClinicalTrial.gov
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    NCT03391934
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    2017-12-31, 1396/10/10

  • Primary outcomes

    #1
    a 6-month period
    a 12-month period
    بازه زمانی 6 ماهه
    بازه زمانی دوازده ماهه

  • Secondary outcomes

    #1
    a 6-month period
    a 12-month period
    بازه زمانی 6 ماهه
    بازه زمانی 12 ماهه
    #2
    a 6-month period
    a 12-month period
    بازه زمانی 6 ماهه
    بازه زمانی 12 ماهه
    #3
    a 6-month period
    a 12-month period
    بازه زمانی 6 ماهه
    بازه زمانی 12 ماهه
    #4
    a 6-month period
    a 12-month period
    بازه زمانی 6 ماهه
    بازه زمانی 12 ماهه
    #5
    Weeks 1, 2, 4, 10, 16 and 22
    Weeks 1, 2, 4, 10, 16, 22, 28, 34, 40 and 46
    هفته 1، 2، 4، 10، 16 و 22
    هفته 1، 2، 4، 10، 16، 22، 28، 34، 40 و 46

  • Recruitment centers

    #1
    Name of recruitment center - English: Ayatollah Taleghani Hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: Dr. Hamid Rezvani, Dr.Sina Salari, Dr.Mojtaba Ghadyani, Dr.Hamid attarian
    Full name of responsible person - Persian:
    Street address - English: Tabnak St., Velenjak Region, Chamran High Way, Tehran, Iran
    Street address - Persian: دکتر حمید رضوانی، دکتر سینا سالاری، دکتر مجتبی قدیانی، دکتر حمید عطاریان
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Ayatollah Taleghani Hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: Dr. Hamid Rezvani, Dr.Sina Salari, Dr.Mojtaba Ghadyani, Dr.Hamid attarian
    Full name of responsible person - Persian: دکتر حمید رضوانی، دکتر سینا سالاری، دکتر مجتبی قدیانی، دکتر حمید عطاریان
    Street address - English: Tabnak St., Velenjak Region, Chamran High Way, Tehran, Iran
    Street address - Persian: ایران، تهران، بزرگراه چمران، ولنجک، خیابان تابناک
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 212365
    Phone: +98 21 2243 2560
    Fax:
    Email: hampegrad@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Dr Safa Najfi Clinic
    Name of recruitment center - Persian: • مطب دکتر صفا نجار نجفی
    Full name of responsible person - English: Dr.Safa Najjar Najafi
    Full name of responsible person - Persian: دکتر صفا نجار نجفی
    Street address - English: Molla sadra street, Tehran, Iran
    Street address - Persian: تهران، ملاصدرا، خیابان پردیس، پلاک 17
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Dr Safa Najfi Clinic
    Name of recruitment center - Persian: مطب دکتر صفا نجفی
    Full name of responsible person - English: Dr.Safa Najjar Najafi
    Full name of responsible person - Persian: دکتر صفا نجار نجفی
    Street address - English: Molla sadra street, Tehran, Iran
    Street address - Persian: تهران، ملاصدرا، خیابان پردیس، پلاک 17
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1234568
    Phone: +98 21 8879 8525
    Fax:
    Email: safa3n@icbc.ir
    Web page address:
    #3
    Name of recruitment center - English: Sheikh mofis clinic
    Name of recruitment center - Persian: کلینیک شیخ مفید
    Full name of responsible person - English: Dr. Fariborz Mokarian, Dr.Ali Hajiqolami,Dr. Ali Reza Sadeghi, Dr.Amir Abbas Nekuee, Dr.Valiollah Me
    Full name of responsible person - Persian: دکتر فریبرز مکاریان، دکتر ولی اله مهرزاد، دکتر امیرعباس نکویی، دکتر علیرضا صادقی، دکتر علی حاجی غلامی، دکتر محسن خانی
    Street address - English: Sheikh mofis St. Alzahra clinic, Isfahan, Iran
    Street address - Persian: اصفهان، خيابان فيض ، خيابان شيخ مفيد ، تقاطع دوم ، كلينيك شيخ مفيد
    City - English: Isfahan
    City - Persian: اصفهان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Sheikh mofis clinic
    Name of recruitment center - Persian: کلینیک شیخ مفید
    Full name of responsible person - English: Dr. Mokarian, Dr. Hajiqolami, Dr. Sadeghi, Dr. Nekuee, Dr. Mehrzad
    Full name of responsible person - Persian: دکتر مکاریان، دکتر مهرزاد، دکتر نکویی، دکتر صادقی، دکتر حاجی غلامی
    Street address - English: Sheikh mofis St. Alzahra clinic, Isfahan, Iran
    Street address - Persian: اصفهان، خيابان فيض ، خيابان شيخ مفيد ، تقاطع دوم
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 987456
    Phone: +98 31 3663 1677
    Fax:
    Email: valimehrzad@yahoo.com
    Web page address:
    #4
    Name of recruitment center - English: Firozgar Hospital
    Name of recruitment center - Persian: • بیمارستان فیروزگر
    Full name of responsible person - English: Dr. Mohsen Razavi
    Full name of responsible person - Persian: دکتر محسن رضوی
    Street address - English: Valiasr Street, Valadi Street, Tehran, Iran
    Street address - Persian: تهران، میدان ولیعصر، خیابان کریم خان زند، خیابان به آفرین
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Firozgar Hospital
    Name of recruitment center - Persian: بیمارستان فیروزگر
    Full name of responsible person - English: Dr. Mohsen Razavi
    Full name of responsible person - Persian: دکتر محسن رضوی
    Street address - English: Valiasr Street, Valadi Street, Tehran, Iran
    Street address - Persian: تهران، میدان ولیعصر، خیابان کریم خان زند، خیابان به آفرین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 654125
    Phone: +98 21 8214 1600
    Fax:
    Email: s_m_raz@yahoo.com
    Web page address:
    #5
    Name of recruitment center - English: Masoud clinic
    Name of recruitment center - Persian: کلینیک مسعود
    Full name of responsible person - English: Dr. Masoud Iravani
    Full name of responsible person - Persian: دکتر مسعود ایروانی
    Street address - English: 19th street. Amirabad. Tehran Iran
    Street address - Persian: تهران، خیابان کارگر شمالی، بالاتر از بزرگراه جلال آل احمد، خیابان 19، پلاک 144
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Masoud clinic
    Name of recruitment center - Persian: کلینیک مسعود
    Full name of responsible person - English: Dr. Masoud Iravani
    Full name of responsible person - Persian: دکتر مسعود ایروانی
    Street address - English: 19th street. Amirabad. Tehran Iran
    Street address - Persian: تهران، خیابان کارگر شمالی، بالاتر از بزرگراه جلال آل احمد، خیابان 19، پلاک 144
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 415263
    Phone: +98 21 8833 6300
    Fax:
    Email: iravani_m@yahoo.com
    Web page address:
    #6
    Name of recruitment center - English: Namazee Hospital
    Name of recruitment center - Persian: بیمارستان نمازی
    Full name of responsible person - English: Dr.Mani Ramzi, Dr. Alireza Rezvani
    Full name of responsible person - Persian: دکتر مانی رمزی دکتر علیرضا رضوانی
    Street address - English: Zand Street, Namaz Square, Shiraz, Fars, Iran
    Street address - Persian: فارس، شیراز، خیابان زند، میدان نمازی
    City - English: Shiraz
    City - Persian: شیراز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Namazee Hospital
    Name of recruitment center - Persian: بیمارستان نمازی
    Full name of responsible person - English: Dr.Mani Ramzi, Dr. Alireza Rezvani
    Full name of responsible person - Persian: دکتر مانی رمزی, دکتر علیرضا رضوانی
    Street address - English: Zand Street, Namaz Square, Shiraz, Fars, Iran
    Street address - Persian: فارس، شیراز، خیابان زند، میدان نمازی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 748596
    Phone: +98 71 3647 4332
    Fax:
    Email: Ramzim@sums.ac.ir
    Web page address:
    #7
    Name of recruitment center - English: Dr Payandeh clinic
    Name of recruitment center - Persian: مطب دکتر مهرداد پاینده
    Full name of responsible person - English: Dr. Mehrdad Payandeh
    Full name of responsible person - Persian: دکتر مهرداد پاینده
    Street address - English: Shahrdari square- Kermanshah- Iran
    Street address - Persian: کرمانشاه، خیابان مدرس، نرسیده به میدان شهرداری، کوچه فخر رازی، پلاک 101
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Dr. Mortazavizadeh Clinic
    Name of recruitment center - Persian: مطب دکتر مرتضوی زاده
    Full name of responsible person - English: Dr. Mohammad Reza Mortazavi Zade
    Full name of responsible person - Persian: دکتر محمدرضا مرتضوی زاده
    Street address - English: No 25, Shahid haj Mohammadi Alley, Yazd, Iran
    Street address - Persian: یزد، ابتدای بلوار کوچه شهید حاج محمدی، پلاک ۲۵
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 956214
    Phone: +98 35 3725 0044
    Fax:
    Email: mortazavizadeh@yahoo.com
    Web page address:
    #8
    Name of recruitment center - English: Dr. Mortazavizadeh Clinic
    Name of recruitment center - Persian: مطب دکتر محمدرضا مرتضوی زاده
    Full name of responsible person - English: Dr. Mohammad Reza Mortazavi Zade
    Full name of responsible person - Persian: دکتر محمدرضا مرتضوی زاده
    Street address - English: Yazd,Yazd province, Iran,
    Street address - Persian: یزد، ابتدای بلوار کوچه شهید حاج محمدی، پلاک ۲۵
    City - English: Yazd
    City - Persian: یزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Shafa Hospital
    Name of recruitment center - Persian: بیمارستان شفا
    Full name of responsible person - English: Dr. Mehran Hosseinzadeh, Dr. Ali Ehsanpour
    Full name of responsible person - Persian: دکتر مهران حسین زاده، دکتر علی احسانپور
    Street address - English: Ahvaz, Khuzestan, Iran
    Street address - Persian: خوزستان، اهواز،گلستان مرکز اموزشي درماني شفا
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 758652
    Phone: +98 61 3374 3281
    Fax:
    Email: hoseinzadehmehran@gmail.com
    Web page address:
    #9
    Name of recruitment center - English: Shafa Hospital
    Name of recruitment center - Persian: بیمارستان شفا اهواز
    Full name of responsible person - English: Dr. Mehran Hosseinzadeh, Dr. Ahmad Ahmad Zadeh
    Full name of responsible person - Persian: دکتر مهران حسین زاده دکتر احمد احمدزاده
    Street address - English: Ahvaz, Khuzestan, Iran
    Street address - Persian: خوزستان، اهواز،گلستان مرکز اموزشي درماني شفا
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
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    Name of recruitment center - English: Emam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Abolghasem Allahyari
    Full name of responsible person - Persian: دکتر ابوالقاسم الهیاری
    Street address - English: Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
    Street address - Persian: خراسان رضوی، مشهد، خیابان ابن سینا، میدان امام رضا
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 526584
    Phone: +98 51 3854 3031
    Fax:
    Email: allahyari.abolghasem@yahoo.com
    Web page address:
    #10
    Name of recruitment center - English: Emam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Abolghasem Allahyari
    Full name of responsible person - Persian: دکتر ابوالقاسم الهیاری
    Street address - English: Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
    Street address - Persian: خراسان رضوی، مشهد، خیابان ابن سینا، میدان امام رضا
    City - English: Mashhad
    City - Persian: مشهد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
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    Name of recruitment center - English: Emam khomini Hospital
    Name of recruitment center - Persian: بیمارستان امام خمینی (ره)
    Full name of responsible person - English: Dr.Seyed Reza Safaeinodehi, Dr. Farhad Shahi
    Full name of responsible person - Persian: دکتر سید رضا صفایی نودهی، دکتر فرهاد شاهی
    Street address - English: End of Keshavarz Blvd., Tehran, Iran
    Street address - Persian: تهران، انتهای بلوار کشاورز، مجتمع درمانی امام خمینی، بیمارستان ولیعصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 5198622
    Phone: +98 21 6658 1593
    Fax:
    Email: F.shahi@yahoo.com
    Web page address:
    #11
    Name of recruitment center - English: Emam khomini Hospital
    Name of recruitment center - Persian: بیمارستان امام خمینی (ره)
    Full name of responsible person - English: Dr.Seyed Reza Safaeinodehi, Dr. Farhad Shahi
    Full name of responsible person - Persian: دکتر سید رضا صفایی نودهی دکتر فرهاد شاهی
    Street address - English: End of Keshavarz Blvd., Tehran, Iran
    Street address - Persian: تهران، انتهای بلوار کشاورز، مجتمع درمانی امام خمینی، بیمارستان ولیعصر
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
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    Name of recruitment center - English: Shohadaye Khalij Fars hospital
    Name of recruitment center - Persian: بیمارستان شهدای خلیج فارس
    Full name of responsible person - English: Dr. Mohammad Reza Ravanbod
    Full name of responsible person - Persian: دکتر محمدرضا روانبد
    Street address - English: Bushehr University of Medical Sciences, Bushehr, Iran
    Street address - Persian: بوشهر ، میدان آزادی ، ابتدای خیابان طالقانی
    City - English: Bushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 45652585
    Phone: +98 77 3345 5375
    Fax:
    Email: drravanbod@yahoo.com
    Web page address:
    #12
    Name of recruitment center - English: Shohadaye Khalij Fars hospital
    Name of recruitment center - Persian: بیمارستان شهدای خلیج فارس
    Full name of responsible person - English: Dr. Mohammad Reza Ravanbod
    Full name of responsible person - Persian: دکتر محمدرضا روانبد
    Street address - English: Bushehr University of Medical Sciences, Bushehr, Iran
    Street address - Persian: بوشهر ، میدان آزادی ، ابتدای خیابان طالقانی
    City - English: Bushehr
    City - Persian: بوشهر
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Bahonar hospital
    Name of recruitment center - Persian: بیمارستان باهنر
    Full name of responsible person - English: Dr. Ali Nemati, Dr. Vahid Moazed
    Full name of responsible person - Persian: دکتر علی نعمتی، دکتر وحید معاضد
    Street address - English: Shahid Gharani street, Kerman, Iran
    Street address - Persian: کرمان، خیابان شهید قرنی غربی
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Country: Iran (Islamic Republic of)
    Postal code: 2584136
    Phone: +98 34 3223 5011
    Fax:
    Email: Moazed_vahid@yahoo.com
    Web page address:
    #13
    Name of recruitment center - English: Bahonar hospital
    Name of recruitment center - Persian: بیمارستان باهنر
    Full name of responsible person - English: Dr. Ali Nemati
    Full name of responsible person - Persian: دکتر علی نعمتی
    Street address - English: Kerman street century martyr, Kerman, Iran
    Street address - Persian: کرمان، خیابان شهید قرنی غربی
    City - English: Kerman
    City - Persian: کرمان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Emam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Hadi Mohammad doust
    Full name of responsible person - Persian: دکتر هادی محمددوست
    Street address - English: Seyed Jamal Odin Asadabadi Street, Bojnurd, North Khorasan, Iran.
    Street address - Persian: خراسان شمالي ، شهرستان بجنورد ، خيابان سيدجمال الدين اسد آبادي
    City - English: bojnurd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 5214658
    Phone: +98 58 4222 8111
    Fax:
    Email: hadi81938@gmail.com
    Web page address:
    #14
    Name of recruitment center - English: Emam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Hadi Mohammad doust
    Full name of responsible person - Persian: دکتر هادی محمددوست
    Street address - English: North Khorasan, bojnurd
    Street address - Persian: خراسان شمالي ، شهرستان بجنورد ، خيابان سيدجمال الدين اسد آبادي
    City - English: bojnurd
    City - Persian: بجنورد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
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    Name of recruitment center - English: Shahid Ghazi hospital
    Name of recruitment center - Persian: بیمارستان شهید قاضی
    Full name of responsible person - English: Dr Nejati, Dr Esfahani, Dr Vaez, Dr Nikanfar, Dr Eyvazi, Dr Hedayati, Dr Chavoshi
    Full name of responsible person - Persian: دکتر نجاتی، دکتر اصفهانی، دکتر واعظ، دکتر نیکانفر، دکتر عیوضی، دکتر هدایتی، دکتر چاوشی، دکتر محمدپور
    Street address - English: Golgasht St, Daneshgah St, Tabriz
    Street address - Persian: تبریز - خیابان دانشگاه - خیابان گل گشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 885544
    Phone: +98 41 3334 3626
    Fax:
    Email: ali_sfhn@yahoo.com
    Web page address:
    #15
    Name of recruitment center - English: Shahid Ghazi hospital
    Name of recruitment center - Persian: بیمارستان شهید قاضی
    Full name of responsible person - English: Dr Nejati, Dr Esfahani, Dr Senaat, Dr Vaez, Dr Nikanfar, Dr Eyvazi, Dr Hedayati, Dr Chavoshi, Dr Asv
    Full name of responsible person - Persian: دکتر نجاتی، دکتر اصفهانی، دکتر صناعت، دکتر واعظ، دکتر نیکانفر، دکتر عیوضی، دکتر هدایتی، دکتر چاوشی، دکتر اسودی، دکتر محمدپور
    Street address - English: Golgasht St, Daneshgah St, Tabriz
    Street address - Persian: تبریز - خیابان دانشگاه - خیابان گل گشت - بیمارستان شهید قاضی
    City - English: Tabriz
    City - Persian: تبریز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Amir hospital
    Name of recruitment center - Persian: بیمارستان امیر
    Full name of responsible person - English: Dr. Alireza Rezvani
    Full name of responsible person - Persian: دکتر علیرضا رضوانی
    Street address - English: Rajaei Blvd, Shiraz, Fars Province,
    Street address - Persian: فارس، شیراز، بلوار شهید رجائی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 45974165
    Phone: +98 71 3632 3731
    Fax:
    Email: Dr.rezvani@hotmail.com
    Web page address:
    #16
    Name of recruitment center - English: Masih Daneshvari hospital
    Name of recruitment center - Persian: بیمارستان مسیح دانشوری
    Full name of responsible person - English: Dr. Adnan Khosravi
    Full name of responsible person - Persian: دکتر عدنان خسروی
    Street address - English: Darabad Street, Tehran
    Street address - Persian: تهران، دارآباد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 552266
    Phone: +98 21 2712 2160
    Fax:
    Email: adkhosravi@yahoo.com
    Web page address:
    #17
    Name of recruitment center - English: Seyyed-al-Shohada hospital
    Name of recruitment center - Persian: بیمارستان سیدالشهدا
    Full name of responsible person - English: Dr. MohammadReza MortazaviZadeh, Dr. MohammadReza Vahidfar
    Full name of responsible person - Persian: دکتر محمدرضا مرتضوی زاده، دکتر محمدرضا وحیدفر
    Street address - English: Imam Khomeini Street, Yazd, Iran
    Street address - Persian: یزد، خیابان امام خمینی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 6546434
    Phone: +98 35 3621 0010
    Fax:
    Email: mortazavizadeh@yahoo.com
    Web page address:
    #18
    Name of recruitment center - English: Rahimi Hospital
    Name of recruitment center - Persian: بیمارستان شهید رحیمی
    Full name of responsible person - English: Dr. Mojtaba Gorji
    Full name of responsible person - Persian: دکتر مجتبی گرجی
    Street address - English: Azado Sq, Khoram Abad, Iran
    Street address - Persian: خرم آباد، میدان آزادی، نرسیده به پل صفوی
    City - English: Khoram Abad
    City - Persian: خرم آباد
    Province: Lorestan
    Country: Iran (Islamic Republic of)
    Postal code: 7893214567
    Phone: +98 21 3333 6143
    Fax:
    Email: mogorji@yahoo.com
    Web page address:
    #19
    Name of recruitment center - English: Rasoul Akram Hospital
    Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
    Full name of responsible person - English: Dr. Mehdi Mirbolouk
    Full name of responsible person - Persian: دکتر مهدی میربلوک
    Street address - English: Gil Sq, Gilan, Iran
    Street address - Persian: رشت، بالاتر از میدان گیل
    City - English: Rasht
    City - Persian: رشت
    Province: Guilan
    Country: Iran (Islamic Republic of)
    Postal code: 1234569874
    Phone: +98 13 3366 2217
    Fax:
    Email: mirboloukmahdi@yahoo.com
    Web page address:
    #20
    Name of recruitment center - English: Rasoul e Akram Hospital
    Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
    Full name of responsible person - English: Dr. Nafiseh Ansari Nezhad, Dr. Farshid Fardad, Dr. Nstaran Khoda Karim
    Full name of responsible person - Persian: دکتر نفیسه انصاری نژاد-دکتر فرشید فرداد- دکتر نسترن خداکریم
    Street address - English: Sattar Khan Street, Tehran, Iran
    Street address - Persian: تهران - ستارخان - خ. نیایش - نبش خیابان منصوری - مجتمع آموزشي درماني حضرت رسول اكرم(ص)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 4563217893
    Phone: +98 21 6651 5001
    Fax:
    Email: drfardad@yahoo.com
    Web page address:
    #21
    Name of recruitment center - English: Ghaem Hospital
    Name of recruitment center - Persian: بیمارستان قائم
    Full name of responsible person - English: Dr. Alireza Bari
    Full name of responsible person - Persian: دکتر علیرضا باری
    Street address - English: Shariati Sq, Mashhad, Iran
    Street address - Persian: خراسان رضوی - مشهد- میدان دکتر شریعتی (تقی آباد)- خیابان احمد آباد- مرکز آموزشی و پژوهشی و درمانی قائم (عج)
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 7897412365
    Phone: +98 51 3840 0000
    Fax:
    Email: dr.alireza.baari@gmail.com
    Web page address:
    #22
    Name of recruitment center - English: Baghie at Allah Hospital
    Name of recruitment center - Persian: بیمارستان بقیه اله
    Full name of responsible person - English: Dr. Mojtaba Ghadiani
    Full name of responsible person - Persian: دکتر مجتبی قدیانی
    Street address - English: Mollasadra Street, Tehran, Iran
    Street address - Persian: میدان ونک خیابان ملاصدرا بعد از شیخ بهایی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 9638527418
    Phone: +98 21 8805 0435
    Fax:
    Email: ghadianymojtaba@yahoo.com
    Web page address:
    #23
    Name of recruitment center - English: Ali Ebn Abitaleb Hospital
    Name of recruitment center - Persian: بیمارستان علی بن ابی طالب
    Full name of responsible person - English: Dr. Alireza Ghazi Zade
    Full name of responsible person - Persian: دکتر علیرضا قاضی زاده
    Street address - English: Taleghani Blvd, Kerman, Iran
    Street address - Persian: کرمان - رفسنجان - بلوار طالقانی - میدان ایت الله سعیدی
    City - English: Rafsanjan
    City - Persian: رفسنجان
    Province: Kerman
    Country: Iran (Islamic Republic of)
    Postal code: 7418529634
    Phone: +98 34 3428 8902
    Fax:
    Email: alireza_gh54@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: CinnaGen company
    Name of organization / entity - Persian: شرکت تحقیقاتی و تولیدی سیناژن
    Full name of responsible person - English: Somayeh Amini
    Full name of responsible person - Persian: سمیه امینی
    Street address - English: No 2, Khorasani deadend, Derakhti St, Dadman St, Shahrak-eGharb
    Street address - Persian: تهران- شهرک غرب- بلوار دادمان- ابتدای خیابان درختی- پلاک 2- شرکت ارکیدفارمد
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: CinnaGen company
    Name of organization / entity - Persian: شرکت تحقیقاتی و تولیدی سیناژن
    Full name of responsible person - English: Haleh Hamedifar
    Full name of responsible person - Persian: هاله حامدی فر
    Street address - English: CinnaGen research and production Company. Simin Dasht Industrial Park, Karaj, Alborz, Iran
    Street address - Persian: ایران، البرز، کرج، شهرک صنعتی سیمین دشت
    City - English: Karaj
    City - Persian: کرج
    Province: Alborz
    Country: Iran (Islamic Republic of)
    Postal code: 6670337 263 98
    Phone: +98 26 3667 0334
    Fax:
    Email: cinnagen@cinnagen.com
    Web page address:
    empty
    Private
    empty
    Domestic
    empty
    Industry

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Orchid Pharmed company
    Name of organization / entity - Persian: شرکت ارکیدفارمد
    Full name of responsible person - English: Ramin Azhdarzadeh
    Full name of responsible person - Persian: رامین اژدرزاده
    Position - English: Pharmacist (PhD), Clinical Trial Manager
    Position - Persian: داروساز- مدیر واحد مطالعات بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.2, khorasani Alley, Derakhti Ave, dadman blvd, Shahrak-e-Gharb
    Street address - Persian: تهران- شهرک غرب- بلوار دادمان- ابتدای خیابان درختی- پلاک 2- شرکت ارکیدفارمد
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1468813112
    Phone: +98 21 4347 3000
    Mobile: +98 914 409 1359
    Fax:
    Email: azhdarzadeh.m@orchidpharmed.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Orchid Pharmed company
    Name of organization / entity - Persian: شرکت ارکیدفارمد
    Full name of responsible person - English: Somayeh Amini
    Full name of responsible person - Persian: سمیه امینی
    Position - English: Medical Manager
    Position - Persian: داروساز- مدیر واحد مدیکال
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.2, khorasani Alley, Derakhti Ave, dadman blvd, Shahrak-e-Gharb
    Street address - Persian: تهران- شهرک غرب- بلوار دادمان- ابتدای خیابان درختی- پلاک 2- شرکت ارکیدفارمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1468813112
    Phone: +98 21 4347 3000
    Mobile: +98 939 807 9606
    Fax:
    Email: amini.s@orchidpharmed.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Orchid Pharmed
    Name of organization / entity - Persian: ارکید فارمد
    Full name of responsible person - English: somayeh Amini
    Full name of responsible person - Persian: سمیه امینی
    Position - English: Pharmacist/Medical manager
    Position - Persian: داروساز- مدیر مدیکال
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 2, Khorasani deadend, Derakhti St, Dadman St, Shahrak-eGharb
    Street address - Persian: تهران- شهرک غرب- بلوار دادمان- ابتدای خیابان درختی- پلاک 2- شرکت ارکیدفارمد
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 4347 3000
    Mobile: 00
    Fax: +98 21 8856 2862
    Email: amini.s@orchidpharmed.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Orchid Pharmed
    Name of organization / entity - Persian: ارکید فارمد
    Full name of responsible person - English: Somayeh Amini
    Full name of responsible person - Persian: سمیه امینی
    Position - English: Pharmacist/Medical manager
    Position - Persian: داروساز- مدیر مدیکال
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 2, Khorasani deadend, Derakhti St, Dadman St, Shahrak-eGharb
    Street address - Persian: تهران- شهرک غرب- بلوار دادمان- ابتدای خیابان درختی- پلاک 2- شرکت ارکیدفارمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1468813112
    Phone: +98 21 4347 3000
    Mobile: +98 939 807 9606
    Fax: +98 21 8856 2862
    Email: amini.s@orchidpharmed.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Orchid Pharmed company
    Name of organization / entity - Persian: شرکت ارکیدفارمد
    Full name of responsible person - English: Ramin Azhdarzadeh
    Full name of responsible person - Persian: رامین اژدرزاده
    Position - English: Pharmacist (PhD), Clinical Trial Manager
    Position - Persian: داروساز- مدیر واحد مطالعات بالینی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.2, khorasani Alley, Derakhti Ave, dadman blvd, Shahrak-e-Gharb
    Street address - Persian: تهران- شهرک غرب- بلوار دادمان- ابتدای خیابان درختی- پلاک 2- شرکت ارکیدفارمد
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 4347 3000
    Mobile: +98 914 409 1359
    Fax: +98 21 8808 8821
    Email:
    Web page address: azhdarzadeh.m@orchidpharmed.com
    contact.organization_id:
    Name of organization / entity - English: Orchid Pharmed company
    Name of organization / entity - Persian: شرکت ارکیدفارمد
    Full name of responsible person - English: Sahar Pedram
    Full name of responsible person - Persian: سحر پدرام
    Position - English: Pharmacist (PhD), Clinical Research Associate
    Position - Persian: داروساز- سوپروایزر واحد مطالعات بالینی
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.2, khorasani Alley, Derakhti Ave, dadman blvd, Shahrak-e-Gharb
    Street address - Persian: تهران- شهرک غرب- بلوار دادمان- ابتدای خیابان درختی- پلاک 2- شرکت ارکیدفارمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1468813112
    Phone: +98 21 4347 3000
    Mobile: +98 912 805 9428
    Fax: +98 21 8808 8821
    Email: pedram.s@orchidpharmed.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    it is not yet known if there will be a plan to make this available
    empty
    در خصوص این موضوع هنوز تصمیمی اتخاذ نشده است.

Protocol summary

Study aim
The aim of this study is to determine the equivalency of efficacy and safety of cetuximab (CinnaGen) versus Erbitux® (Merck) in progression free survival (PFS) when added to FOLFIRI (irinotecan plus leucovorin/ 5-fluorouracil continuous infusion) in patients with metastatic colorectal cancer (mCRC) without mutations in RAS genes
Design
A phase III, Active-controlled, Parallel, double-blind, randomized clinical trial
Settings and conduct
This is a multicenter, double-blinded study.
Participants/Inclusion and exclusion criteria
Inclusion: • Age of 18 years or older • Histologically confirmed adenocarcinoma of the colon or rectum • Having one or more bi-dimensionally measurable lesions as defined by RECIST Criteria • Adequate organ and marrow function Exclusion: • Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy • Adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial • The use of radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial • Female patients who are pregnant or lactating chemically or biologically similar to Cetuximab, irinotecan, 5-FU or leucovorin. • Patients with a history of another primary malignancy in less than 5 years, • Inability to comply with study and/or follow-up procedures
Intervention groups
Cetuximab 400 mg/m2 for the first and 250 mg/m2 for subsequent doses
Main outcome variables
Primary Endpoint: Progression Free Survival Secondary Endpoints: Overall Survival, Time to Treatment Failure, Objective Response Rate, Safety, and Immunogenicity.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2017110821315N10
Registration date: 2017-11-15, 1396/08/24
Registration timing: prospective

Last update: 2019-05-12, 1398/02/22
Update count: 3
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
CinnaGen Company
Expected recruitment start date
2017-11-30, 1396/09/09
Expected recruitment end date
2019-11-30, 1398/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Phase III, randomized, two armed, parallel, double blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Cetuximab (produced by CinnaGen) and FOLFIRI compared with Erbitux® (Cetuximab, the reference drug, produced by Merck Company) and FOLFIRI as first-line treatment for RAS wild-type Metastatic Colorectal Cancer
Public title
An equivalency clinical trial to determine the efficacy and safety between Cetuximab (produced by CinnaGen) compared with Erbitux® in RAS wild-type Metastatic Colorectal Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male or female Age of 18 years or older histologically confirmed adenocarcinoma of the colon or rectum having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria metastatic disease that could not be resected for curative purposes immunohistochemical evidence of tumor EGFR expression (expanded wild-type RAS) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less life expectancy of longer than 3 months (by clinical assessment) adequate organ and marrow function.
Exclusion criteria:
Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy the use of radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial female patients who are pregnant or lactating patients with a history of another primary malignancy in less than 5 years, with the exception of non-melanoma skin cancer and carcinoma in-situ of uterine cervix patients with history of allergic reactions attributed to compounds chemically or biologically similar to Cetuximab, irinotecan, 5-FU or leucovorin adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial inability to comply with study and/or follow-up procedures Subjects with known infection with HIV, HBV, HCV
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 234
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be assigned to treatment with the use of a dynamic randomization algorithm that will be designed to achieve overall balance between groups; randomization will be stratified according to site of primary tumor and number of metastasis (1 or more than 1) with 1:2 allocation ratio. After randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the 2 first letter of the first name, the 2 first letter of the first surname) and 3 numbers (center code). Moreover, the code described is followed by study unique identification consisting of first three letters of the generic name (which is CET-) and 3 numbers (corresponding to the randomization number), e.g. ABCD001CET-001. The randomization number will be assigned in a consecutive way. concealment process: Randomization will not be exposed to those conducting the study and will be provided in sealed opaque envelopes with successive numbers. The original paper of randomized remains in the CRO Trial and after checking eligibility criteria, the randomization code is given to the prescriber by telephone. Randomization will not be exposed to the trial executers and will be provided to the researcher of each center in non-transparent sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both cetuximab products are indistinguishable for patients and health care providers. Since the route of administration is infusion, and the size and shape of the vial, cap, seal, aluminum and the color are quite similar, it is not possible to distinguish the type of brand from the appearance of vials and it will be possible to make patients blind about the treatment group which they have been allocated to
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
ClinicalTrial.gov
Secondary trial Id
NCT03391934
Registration date
2017-12-31, 1396/10/10

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Science
Street address
Tabnak St., Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
134423235
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.SBMU.REC.1396.228

2

Ethics committee
Name of ethics committee
Tabriz University of Medical science
Street address
Tabriz University of Medical science,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
41544
Approval date
2017-10-15, 1396/07/23
Ethics committee reference number
IR.TABRIZ.REC.1396.603

Health conditions studied

1

Description of health condition studied
RAS wild-type Metastatic Colorectal Cancer
ICD-10 code
C18.9, C20
ICD-10 code description
Malignant neoplasm of colon, Malignant neoplasm of rectum

Primary outcomes

1

Description
Assessment of Progression-Free Survival (PFS) time of Cetuximab and Erbitux®
Timepoint
a 12-month period
Method of measurement
PFS is defined as the time from the date of randomization to the first date of documentation progression (per investigator assessment) or death as a result of any cause.

Secondary outcomes

1

Description
Overall survival
Timepoint
a 12-month period
Method of measurement
the time from date of randomization to date of death due to any cause

2

Description
Objective response rate
Timepoint
a 12-month period
Method of measurement
RECIST criteria (Response Evaluation Criteria in Solid Tumors)

3

Description
Time to treatment failure
Timepoint
a 12-month period
Method of measurement
- Time of treatment failures define as the time from the date of randomization to the date of each of the following, - The treatment modalities did not destroy or modify the cancer cell. - The tumor either became larger (disease progression) or stayed the same size after treatment, - Death from any cause - Discontinuation of treatment

4

Description
Safety and frequency of AEs
Timepoint
a 12-month period
Method of measurement
Safety wills assess on the basis of reports of adverse events, laboratory-test results, and vital sign measurements

5

Description
Immunogenicity
Timepoint
Weeks 1, 2, 4, 10, 16, 22, 28, 34, 40 and 46
Method of measurement
assessment (antidrug antibody [ADA] and neutralizing antibody [nAb])

Intervention groups

1

Description
CinnaGen Cetuximab (produced by CinnaGen) 400 mg/m2 for the first infusion, then weekly intravenous infusions of 250 mg/m2, every week for 6 months
Category
Treatment - Drugs

2

Description
Erbitux® 400 mg/m2 for the first infusion, then weekly intravenous infusions of 250 mg/m2, every week for 6 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Dr. Hamid Rezvani, Dr.Sina Salari, Dr.Mojtaba Ghadyani, Dr.Hamid attarian
Street address
Tabnak St., Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
212365
Phone
+98 21 2243 2560
Email
hampegrad@gmail.com

2

Recruitment center
Name of recruitment center
Dr Safa Najfi Clinic
Full name of responsible person
Dr.Safa Najjar Najafi
Street address
Molla sadra street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1234568
Phone
+98 21 8879 8525
Email
safa3n@icbc.ir

3

Recruitment center
Name of recruitment center
Sheikh mofis clinic
Full name of responsible person
Dr. Mokarian, Dr. Hajiqolami, Dr. Sadeghi, Dr. Nekuee, Dr. Mehrzad
Street address
Sheikh mofis St. Alzahra clinic, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
987456
Phone
+98 31 3663 1677
Email
valimehrzad@yahoo.com

4

Recruitment center
Name of recruitment center
Firozgar Hospital
Full name of responsible person
Dr. Mohsen Razavi
Street address
Valiasr Street, Valadi Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
654125
Phone
+98 21 8214 1600
Email
s_m_raz@yahoo.com

5

Recruitment center
Name of recruitment center
Masoud clinic
Full name of responsible person
Dr. Masoud Iravani
Street address
19th street. Amirabad. Tehran Iran
City
Tehran
Province
Tehran
Postal code
415263
Phone
+98 21 8833 6300
Email
iravani_m@yahoo.com

6

Recruitment center
Name of recruitment center
Namazee Hospital
Full name of responsible person
Dr.Mani Ramzi, Dr. Alireza Rezvani
Street address
Zand Street, Namaz Square, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
748596
Phone
+98 71 3647 4332
Email
Ramzim@sums.ac.ir

7

Recruitment center
Name of recruitment center
Dr. Mortazavizadeh Clinic
Full name of responsible person
Dr. Mohammad Reza Mortazavi Zade
Street address
No 25, Shahid haj Mohammadi Alley, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
956214
Phone
+98 35 3725 0044
Email
mortazavizadeh@yahoo.com

8

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr. Mehran Hosseinzadeh, Dr. Ali Ehsanpour
Street address
Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
758652
Phone
+98 61 3374 3281
Email
hoseinzadehmehran@gmail.com

9

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Abolghasem Allahyari
Street address
Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
526584
Phone
+98 51 3854 3031
Email
allahyari.abolghasem@yahoo.com

10

Recruitment center
Name of recruitment center
Emam khomini Hospital
Full name of responsible person
Dr.Seyed Reza Safaeinodehi, Dr. Farhad Shahi
Street address
End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
5198622
Phone
+98 21 6658 1593
Email
F.shahi@yahoo.com

11

Recruitment center
Name of recruitment center
Shohadaye Khalij Fars hospital
Full name of responsible person
Dr. Mohammad Reza Ravanbod
Street address
Bushehr University of Medical Sciences, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45652585
Phone
+98 77 3345 5375
Email
drravanbod@yahoo.com

12

Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Dr. Ali Nemati, Dr. Vahid Moazed
Street address
Shahid Gharani street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
2584136
Phone
+98 34 3223 5011
Fax
Email
Moazed_vahid@yahoo.com

13

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Hadi Mohammad doust
Street address
Seyed Jamal Odin Asadabadi Street, Bojnurd, North Khorasan, Iran.
City
bojnurd
Province
North Khorasan
Postal code
5214658
Phone
+98 58 4222 8111
Email
hadi81938@gmail.com

14

Recruitment center
Name of recruitment center
Shahid Ghazi hospital
Full name of responsible person
Dr Nejati, Dr Esfahani, Dr Vaez, Dr Nikanfar, Dr Eyvazi, Dr Hedayati, Dr Chavoshi
Street address
Golgasht St, Daneshgah St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
885544
Phone
+98 41 3334 3626
Email
ali_sfhn@yahoo.com

15

Recruitment center
Name of recruitment center
Amir hospital
Full name of responsible person
Dr. Alireza Rezvani
Street address
Rajaei Blvd, Shiraz, Fars Province,
City
Shiraz
Province
Fars
Postal code
45974165
Phone
+98 71 3632 3731
Email
Dr.rezvani@hotmail.com

16

Recruitment center
Name of recruitment center
Masih Daneshvari hospital
Full name of responsible person
Dr. Adnan Khosravi
Street address
Darabad Street, Tehran
City
Tehran
Province
Tehran
Postal code
552266
Phone
+98 21 2712 2160
Email
adkhosravi@yahoo.com

17

Recruitment center
Name of recruitment center
Seyyed-al-Shohada hospital
Full name of responsible person
Dr. MohammadReza MortazaviZadeh, Dr. MohammadReza Vahidfar
Street address
Imam Khomeini Street, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
6546434
Phone
+98 35 3621 0010
Email
mortazavizadeh@yahoo.com

18

Recruitment center
Name of recruitment center
Rahimi Hospital
Full name of responsible person
Dr. Mojtaba Gorji
Street address
Azado Sq, Khoram Abad, Iran
City
Khoram Abad
Province
Lorestan
Postal code
7893214567
Phone
+98 21 3333 6143
Email
mogorji@yahoo.com

19

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr. Mehdi Mirbolouk
Street address
Gil Sq, Gilan, Iran
City
Rasht
Province
Guilan
Postal code
1234569874
Phone
+98 13 3366 2217
Email
mirboloukmahdi@yahoo.com

20

Recruitment center
Name of recruitment center
Rasoul e Akram Hospital
Full name of responsible person
Dr. Nafiseh Ansari Nezhad, Dr. Farshid Fardad, Dr. Nstaran Khoda Karim
Street address
Sattar Khan Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4563217893
Phone
+98 21 6651 5001
Email
drfardad@yahoo.com

21

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Alireza Bari
Street address
Shariati Sq, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
7897412365
Phone
+98 51 3840 0000
Email
dr.alireza.baari@gmail.com

22

Recruitment center
Name of recruitment center
Baghie at Allah Hospital
Full name of responsible person
Dr. Mojtaba Ghadiani
Street address
Mollasadra Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
9638527418
Phone
+98 21 8805 0435
Email
ghadianymojtaba@yahoo.com

23

Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Hospital
Full name of responsible person
Dr. Alireza Ghazi Zade
Street address
Taleghani Blvd, Kerman, Iran
City
Rafsanjan
Province
Kerman
Postal code
7418529634
Phone
+98 34 3428 8902
Email
alireza_gh54@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
CinnaGen company
Full name of responsible person
Haleh Hamedifar
Street address
CinnaGen research and production Company. Simin Dasht Industrial Park, Karaj, Alborz, Iran
City
Karaj
Province
Alborz
Postal code
6670337 263 98
Phone
+98 26 3667 0334
Email
cinnagen@cinnagen.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CinnaGen company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Orchid Pharmed company
Full name of responsible person
Somayeh Amini
Position
Medical Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No.2, khorasani Alley, Derakhti Ave, dadman blvd, Shahrak-e-Gharb
City
Tehran
Province
Tehran
Postal code
1468813112
Phone
+98 21 4347 3000
Fax
Email
amini.s@orchidpharmed.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Orchid Pharmed
Full name of responsible person
Somayeh Amini
Position
Pharmacist/Medical manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 2, Khorasani deadend, Derakhti St, Dadman St, Shahrak-eGharb
City
Tehran
Province
Tehran
Postal code
1468813112
Phone
+98 21 4347 3000
Fax
+98 21 8856 2862
Email
amini.s@orchidpharmed.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Orchid Pharmed company
Full name of responsible person
Sahar Pedram
Position
Pharmacist (PhD), Clinical Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No.2, khorasani Alley, Derakhti Ave, dadman blvd, Shahrak-e-Gharb
City
Tehran
Province
Tehran
Postal code
1468813112
Phone
+98 21 4347 3000
Fax
+98 21 8808 8821
Email
pedram.s@orchidpharmed.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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