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A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study of AryoTrust™ (AryogenTrastuzumab) efficacy and safety in Human Epidermal Growth Factor Receptor 2–Positive breast cancer in comparison to Herceptin® (Genentech/Roche) control.

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History
# Registration date Revision Id
3 2018-08-15, 1397/05/24 56545
2 2018-08-12, 1397/05/21 56359
1 2016-06-25, 1395/04/05 6573
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  • Protocol summary

    This trial will be initiated from July 2016 and 108 patients with breast cancer recruited from the 18 centers. All centers implement same protocol and procedures by using same SOPs which will be accompanied by training of personnel at the beginning, throughout and at the end of the trial. Regular and strict monitoring visits are provided to ensure all processes will be carried out in accordance with GCP. Probable variation of eligibility criteria and evaluation criteria will be resolved through investigator meetings.
    This trial will be initiated from July 2016 and 108 patients with breast cancer recruit from the 18 centers. All centers implement same protocol and procedures. Variation of evaluation criteria and schemes will be reduced by investigator meetings, training of personnel in advance of the trial, and by careful monitoring during the trial. After confirmation of the eligibility of the patient and signing the informed consent form, the patients will be allocated to treatment groups according to the trial randomization master sheet (created by CRO Trial). Both products are indistinguishable for patients and health care providers and they will be blind to treatment allocation.
    این مطالعه از تیر ماه 1395 آغاز خواهد گردید و تعداد 108 بیمار از 18 سایت بیمارگیری وارد مطالعه خواهند گردید. تمامی مراکز پروتکل و روش های یکسانی را بر اساس فرایند استاندارد اجرا خواهند نمود. تلاش خواهد شد تا انحراف از شاخص های ورود و زمینه مطالعه از طریق برگزاری جلسه محققین، آموزش پرسنل قبل از شروع مطالعه و نیز انجام پایش در طول انجام مطالعه، به حداقل رسانده شود.
    این مطالعه از تیر ماه 1395 آغاز خواهد گردید و تعداد 108 بیمار از 18 سایت بیمارگیری وارد مطالعه خواهند گردید. تمامی مراکز پروتکل و روش های یکسانی را بر اساس فرایند استاندارد اجرا خواهند نمود. تلاش خواهد شد تا انحراف از شاخص های ورود و زمینه مطالعه از طریق برگزاری جلسه محققین، آموزش پرسنل قبل از شروع مطالعه و نیز انجام پایش در طول انجام مطالعه، به حداقل رسانده شود. بیماران پس از امضای رضایتنامه آگاهانه و انجام غربالگری و داشتن شرایط ورود، طبق لیست رندومیزیشن که توسط CRO Trial تهیه شده، در یکی از گروه های درمانی قرار می گیرند. هر دو دارو کاملا مشابه هم هستند و بیماران و محققین نسبت به نوع دارو کور هستند.
    18-55 years old female patients with HER2+ breast cancer, newly diagnosed stage III (locally advanced) or in-operable stage II are candidates for participation. patients with metastatic disease, History of any other malignancy or previous chemotherapy, significant cardiovascular desease, Hematologic abnormalities,liver and kidney dysfunction and Pregnant, lactating women are excluded
    18-70 years old female patients with HER2+ breast cancer, newly diagnosed stage III (locally advanced) or in-operable stage II are candidates for participation.
    خانم های بین سنین 18 تا 70 سال که سرطان پستان HER2 مثبت با با تومورهای Stage III تازه تشخیص داده شده (با پیشرفت موضعی) یا Stage II غیر قابل جراحی دارند، کاندیدای شرکت در مطالعه هستند. بیماران با تشخیص سرطان متاستاتیک پستان و یا سایر بدخیمی ها، سابقه شیمی درمانی قبلی، هرگونه مشکلات قلبی و عروقی، مشکلات جدی کبدی و کلیوی و زنان باردار یا شیرده وارد مطالعه نمی شوند.
    خانم های بین سنین 18 تا 70 سال که سرطان پستان HER2 مثبت با با تومورهای Stage III تازه تشخیص داده شده (با پیشرفت موضعی) یا Stage II غیر قابل جراحی دارند، کاندیدای شرکت در مطالعه هستند.
    This study has two arms with 1:1 allocation. subjects in group I will receive AryoTrust (AryoGen Pharmed) plus Docetaxel every 3 weeks. subjects in group II will receive Herceptin® (Genentech/Roche) plus Docetaxel every 3 weeks
    This study has two arms with 1:1 allocation. subjects in group I will receive AryoTrust (AryoGen Pharmed) plus Docetaxel every 3 weeks. subjects in group II will receive Herceptin® (Genentech/Roche) plus Docetaxel every 3 weeks. Both groups will receive Doxorubicin + Cyclophosphamid for 4 cycles before randomization.
    بیماران با نسبت یک به یک به دو گروه تقسیم می شوند. گروه اول داروی تراستوزومب (ساخت شرکت آریوژن) را هر 3 هفته به همراه دوسه تکسول دریافت خواهند کرد و گروه دوم داروی تراستوزومب (ساخت شرکت Roche) را هر 3 هفته به همراه دوسه تکسول دریافت خواهند کرد. هر دو گروه قبل از انجام تصادفی سازی به مدت 4 سیکل 14 روزه تحت درمان با داروی دوکسوروبیسین و سیکلوفسفاماید قرار می گیرند.
    بیماران با نسبت یک به یک به دو گروه تقسیم می شوند. گروه اول داروی تراستوزومب (ساخت شرکت آریوژن) را هر 3 هفته به همراه دوسه تکسول دریافت خواهند کرد و گروه دوم داروی تراستوزومب (ساخت شرکت Roche) را هر 3 هفته به همراه دوسه تکسول دریافت خواهند کرد. هر دو گروه قبل از انجام تصادفی سازی به مدت 4 سیکل تحت درمان با داروی دوکسوروبیسین و سیکلوفسفاماید قرار می گیرند.

  • General information

    18-70 years old female patients
    Patients with newly diagnosed stage III(locally advanced) or in-operable stage II (due to sizes larger than 5 cm or high tumor to breast ratio) tumors are candidates for participation
    Willing and able to sign an informed consent
    Pathological diagnosis of adenocarcinoma of the breast
    ECOG status of 0-1
    With any ER/PR status
    HER2 positive (Immunohistochemical (IHC) 2+ intensity, amplification of the HER2 gene on fluorescence in situ hybridization (FISH+ ) or HER2 positive results of Chromogenic in situ hybridization (CISH)). o NOTE: ductal carcinoma in situ (DCIS) components should not be consideredin the determination of degree of IHC staining or FISH amplification
    18-70 years old female patients
    Patients with newly diagnosed stage III(locally advanced) or in-operable stage II (due to sizes larger than 5 cm or high tumor to breast ratio) tumors are candidates for participation
    Willing and able to sign an informed consent
    Pathological diagnosis of adenocarcinoma of the breast
    ECOG status of 0-1
    With any ER/PR status
    HER2 positive
    بیماران زن 18 تا 70 سال
    بیماران تازه تشخیص داده شده stage 3، یا stage 2 غیر قابل جراحی(به دلیل بزرگتر بودن سایز تومور از 5 سانتی متر، یا نسبت بالای تومور به سینه)
    مایل و قادر به امضای رضایت آگاهانه
    تشخیص پاتولوژی آدنوکارسینوما پستان
    اندازه ECOG بین 0-1
    با هر شرایط ER/PR
    HER2 مثبت (شدت +2 IHC، تقویت ژن HER2 در FISH+ یا نتایج مثبت HER2 در CISH) نکته: اجزای کارسینوم مجرایی درجا (DCIS) نباید در تعیین درجه ارنگ آمیزی IHC یا تقویت FISH در نظر گرفته شود.
    بیماران زن 18 تا 70 سال
    بیماران تازه تشخیص داده شده stage 3، یا stage 2 غیر قابل جراحی(به دلیل بزرگتر بودن سایز تومور از 5 سانتی متر، یا نسبت بالای تومور به سینه)
    مایل و قادر به امضای رضایت آگاهانه
    تشخیص پاتولوژی آدنوکارسینوما پستان
    اندازه ECOG بین 0-1
    با هر شرایط ER/PR
    HER2 مثبت

  • Secondary Ids

    #1
    empty
    clinicaltrial.gov
    empty
    NCT03425656
    empty
    2018-06-02, 1397/03/12

  • Ethics committees

    #1
    it.tums.rec.1395.2730
    ir.tums.rec.1395.2730

  • Secondary outcomes

    #1
    number of mastectomy patients compared to the total patients
    number of mastectomy or Breast conservative surgery
    تعداد بیماران ماستکتومی شده نسبت به کل بیماران
    تعداد جراحی های توتال ماستکتومی یا Breast conservative surgery

  • Intervention groups

    #1
    Intervention group: All patients are scheduled to receive AC-Docetaxel+Trastuzumab regimen as detailed bellow: Doxorubicin + Cyclophosphamide phase: Cycle length: 21 days. Total cycles: 4 cycles Doxorubicin, 60 mg/m2 IV, 1 per day Cyclophosphamide,600 mg/m2 IV, 1 per day Docetaxel + AryoTrust™ phase: Docetaxel + AryoTrust™ phase: Cycle length: 21 days. Total cycles: 4 cycles Docetaxel + AryoTrust™ phase: Cycle length: 21 days. Total cycles: 4 cycles Docetaxel, 100 mg/m2 IV AryoTrust™, 8 mg/kg IV loading dose (at cycle 1), followed by 6 mg/kg at subsequent cycles
    Intervention group: All patients are scheduled to receive Doxorubicin + Cyclophosphamide/Docetaxel+AryoTrust regimen as detailed bellow: Doxorubicin + Cyclophosphamide phase: (Cycle length: 14 days.Total cycles: 4) CyclesDoxorubicin, 60 mg/m2 IV + Cyclophosphamide,600 mg/m2 IV. Docetaxel + AryoTrust™ phase: (Cycle length: 21 days.Total cycles: 4 cycles) Docetaxel, 100 mg/m2 IV, AryoTrust™(Produced by AryoGEN Pharmed) 8 mg/kg IV loading dose (at cycle 1), followed by 6 mg/kg at subsequent cycles
    گروه مداخله: تمام بیماران گروه مداخله رژیم داروییAC-Docetaxel+Trastuzumab را به شرح زیر دریافت میکنند : فاز Doxorubicin + Cyclophosphamide:چهار دوره 21 روزه Doxorubicin, 60 mg/m2 IV Cyclophosphamide,600 mg/m2 IV فاز Docetaxel + AryoTrust™:چهار دوره 21 روزه Docetaxel, 100 mg/m2 IV AryoTrust™, 8 mg/kg IV
    گروه مداخله: تمام بیماران در این گروه رژیم دارویی دوکسوروبیسین + سیکلوفسفامید/ آریوتراست + دوسه تکسل را به شکل زیر دریافت می کنند: فاز دوکسوروبیسین + سیکلوفسفامید (هر 14 روز به مدت 4 سیکل): دوکسوروبیسین به میزان 60mg/m2 به صورت وریدی به همراه سیکلوفاسفامید به میزان 600mg/m2 به صورت وریدی. فاز آریوتراست + دوسه تکسل (هر 21 روز به مدت 4 سیکل): دوسه تکسل به میزان 100mg/m2 به صورت وریدی به همراه آریوتراست (ساخت شرکت آریوژن فارمد) به میزان 8mg/kg برای سیکل اول و 6mg/kg برای سیکل های بعدی
    #2
    Control Group: Doxorubicin + Cyclophosphamide phase: Cycle length: 21 days. Total cycles: 4 cycles Doxorubicin,60 mg/m2 IV, 1 day Cyclophosphamide, 600 mg/m2 IV, 1 day Docetaxel+ trastuzumab phase: Cycle length: 21 days. Total cycles: 4 cycles Docetaxel, 100 mg/m2 IV Herceptin®, 8 mg/kg IV loading dose (at cycle 1), followed by 6 mg/kg at subsequent cycles
    Control Group: All patients are scheduled to receive Doxorubicin + Cyclophosphamide/Docetaxel+Herceptin regimen as detailed bellow: Doxorubicin + Cyclophosphamide phase: (Cycle length: 14 days.Total cycles: 4) CyclesDoxorubicin, 60 mg/m2 IV + Cyclophosphamide,600 mg/m2 IV. Docetaxel + Herceptin phase: (Cycle length: 21 days.Total cycles: 4 cycles) Docetaxel, 100 mg/m2 IV, Herceptin (Produced by Roche) 8 mg/kg IV loading dose (at cycle 1), followed by 6 mg/kg at subsequent cycles
    تمام بیماران گروه کنترل رژیم داروییAC-Docetaxel+Trastuzumab را به شرح زیر دریافت میکنند فاز Doxorubicin + Cyclophosphamide : چهار دوره 21 روزه Doxorubicin,60 mg/m2 IV, Cyclophosphamide, 600 mg/m2 IV, فاز Docetaxel+ trastuzumab: چهار دوره 21 روزه Docetaxel, 100 mg/m2 IV, Herceptin®, 8 mg/kg IV.
    گروه کنترل: تمام بیماران در این گروه رژیم دارویی دوکسوروبیسین + سیکلوفسفامید/ هرسپتین + دوسه تکسل را به شکل زیر دریافت می کنند: فاز دوکسوروبیسین + سیکلوفسفامید (هر 14 روز به مدت 4 سیکل): دوکسوروبیسین به میزان 60mg/m2 به صورت وریدی به همراه سیکلوفاسفامید به میزان 600mg/m2 به صورت وریدی. فاز هرسپتین + دوسه تکسل (هر 21 روز به مدت 4 سیکل): دوسه تکسل به میزان 100mg/m2 به صورت وریدی به همراه هرسپتین (ساخت شرکت Roche) به میزان 8mg/kg برای سیکل اول و 6mg/kg برای سیکل های بعدی

Protocol summary

Study aim
The aim of this study is to assess non inferiority of AryoTrust (AryoGEN Pharmed) compared to Herceptin (Roche)
Design
This is a Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study with a 1:1 allocation
Settings and conduct
This trial will be initiated from July 2016 and 108 patients with breast cancer recruit from the 18 centers. All centers implement same protocol and procedures. Variation of evaluation criteria and schemes will be reduced by investigator meetings, training of personnel in advance of the trial, and by careful monitoring during the trial. After confirmation of the eligibility of the patient and signing the informed consent form, the patients will be allocated to treatment groups according to the trial randomization master sheet (created by CRO Trial). Both products are indistinguishable for patients and health care providers and they will be blind to treatment allocation.
Participants/Inclusion and exclusion criteria
18-70 years old female patients with HER2+ breast cancer, newly diagnosed stage III (locally advanced) or in-operable stage II are candidates for participation.
Intervention groups
This study has two arms with 1:1 allocation. subjects in group I will receive AryoTrust (AryoGen Pharmed) plus Docetaxel every 3 weeks. subjects in group II will receive Herceptin® (Genentech/Roche) plus Docetaxel every 3 weeks. Both groups will receive Doxorubicin + Cyclophosphamid for 4 cycles before randomization.
Main outcome variables
Pathologic Complete Response

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201606226135N7
Registration date: 2016-06-25, 1395/04/05
Registration timing: prospective

Last update: 2018-08-16, 1397/05/25
Update count: 2
Registration date
2016-06-25, 1395/04/05
Registrant information
Name
Hamed Hosseini
Name of organization / entity
Clinical Trial Center (CTC),Tehran University of Medical Sciences (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 3546
Email address
hhosseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
All expenses of this study including patients’ treatment and medicines, study conduct and performing and research related injuries compensation will be provided by Aryogen pharmed co.
Expected recruitment start date
2016-07-02, 1395/04/12
Expected recruitment end date
2017-07-03, 1396/04/12
Actual recruitment start date
2016-07-09, 1395/04/19
Actual recruitment end date
2018-06-11, 1397/03/21
Trial completion date
empty
Scientific title
A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study of AryoTrust™ (AryogenTrastuzumab) efficacy and safety in Human Epidermal Growth Factor Receptor 2–Positive breast cancer in comparison to Herceptin® (Genentech/Roche) control.
Public title
Efficacy and safety in AryoTrust™ (Aryogen trastuzumab) vs Herceptin® (Genentech/Roche trastuzumab), a non inferiority trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-70 years old female patients Patients with newly diagnosed stage III(locally advanced) or in-operable stage II (due to sizes larger than 5 cm or high tumor to breast ratio) tumors are candidates for participation Willing and able to sign an informed consent Pathological diagnosis of adenocarcinoma of the breast ECOG status of 0-1 With any ER/PR status HER2 positive
Exclusion criteria:
Clinical or radiologic evidence of metastatic disease History of any other malignancy including previous breast cancer, second non-breast malignant disease History of previous chemotherapy Left ventricular ejection fraction [LVEF] <55% confirmed by echo cardiogram within 3 months before registration Any prior myocardial infarction, History of documented congestive heart failure (CHF) Any prior history of arrhythmia or cardiac vascular disease requiring medications or clinically significant Current use of medications for treatment of angina pectoris Current uncontrolled hypertension (diastolic > 100 mmHg or systolic > 200 mmHg) A severe conduction abnormality (having pacemaker or diagnosed by the ECG) and any other significant cardiovascular disease Hematologic abnormalities including baseline Absolute NeutrophilCount (ANC) of≤1,500/µL or platelet count ≤ 100,000/µL Liver dysfunction including : Alanine amino transferase(ALT) and/or aspartate amino transferase (AST) ≥3 Upper Limit Normal (ULN), Alkaline phosphatase (ALP) ≥3 ͯ ULN serum, total bilirubin > 1.5 ULN Renal dysfunction, defined as serum creatinin ≥2.5 mg/dL Pregnant, lactating women or women of childbearing potential who are not willing to use adequate contraception
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 108
Actual sample size reached: 108
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is based on blocked randomization. Patient's allocation will be carried on 1:1 allocation ratio by 27 blocks (length of each block is 4). Randomization sequence will be generated using the random generation command in Microsoft Excel (RANDBETWEEN)
Blinding (investigator's opinion)
Triple blinded
Blinding description
Both trastuzumab products are indistinguishable for patients and health care providers. So it will be possible to make patients blind about the treatment group which they have been allocated to. In addition to this, the outcome evaluators and data managers (data analyzer) will not be aware of patients’ allocations.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
clinicaltrial.gov
Secondary trial Id
NCT03425656
Registration date
2018-06-02, 1397/03/12

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical science, Medical Ethics Committee
Street address
Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
ir.tums.rec.1395.2730

2

Ethics committee
Name of ethics committee
Isfehan university of medical science
Street address
دانشگاه علوم پزشکی اصفهان
City
isfehan
Province
Isfehan
Postal code
81746-73461
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.MUI.REC.1395.4.041

Health conditions studied

1

Description of health condition studied
breast cancer patients with HER2-positive
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
pathologic Complete Response (pCR)
Timepoint
following completion of neoadjuvant systemic therapy
Method of measurement
the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes

Secondary outcomes

1

Description
clinical Complete Response (cCR)
Timepoint
after completion of neoadjuvant systemic therapy
Method of measurement
Disappearance of lesions in imaging. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm

2

Description
clinical Partial Response (cPR)
Timepoint
after completion of neoadjuvant systemic therapy
Method of measurement
At least a 30% decrease in the sum of diameters of target lesions through imaging

3

Description
clinically Stable Disease (cSD)
Timepoint
after completion of neoadjuvant systemic therapy
Method of measurement
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD through imaging

4

Description
clinical Progressive Disease (cPD)
Timepoint
after completion of neoadjuvant systemic therapy
Method of measurement
at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm through imaging

5

Description
clinical Objective Response(cOR)
Timepoint
after completion of neoadjuvant systemic therapy
Method of measurement
cOR= cCR+ cPR

6

Description
breast conservation rate
Timepoint
After surgery
Method of measurement
number of mastectomy or Breast conservative surgery

7

Description
Immunogenicity
Timepoint
Week 10, 13, 19 and 26
Method of measurement
Laboratory results

8

Description
Adverse events
Timepoint
Every cycle
Method of measurement
Laboratory data and patient assessments

Intervention groups

1

Description
Intervention group: All patients are scheduled to receive Doxorubicin + Cyclophosphamide/Docetaxel+AryoTrust regimen as detailed bellow: Doxorubicin + Cyclophosphamide phase: (Cycle length: 14 days.Total cycles: 4) CyclesDoxorubicin, 60 mg/m2 IV + Cyclophosphamide,600 mg/m2 IV. Docetaxel + AryoTrust™ phase: (Cycle length: 21 days.Total cycles: 4 cycles) Docetaxel, 100 mg/m2 IV, AryoTrust™(Produced by AryoGEN Pharmed) 8 mg/kg IV loading dose (at cycle 1), followed by 6 mg/kg at subsequent cycles
Category
Treatment - Drugs

2

Description
Control Group: All patients are scheduled to receive Doxorubicin + Cyclophosphamide/Docetaxel+Herceptin regimen as detailed bellow: Doxorubicin + Cyclophosphamide phase: (Cycle length: 14 days.Total cycles: 4) CyclesDoxorubicin, 60 mg/m2 IV + Cyclophosphamide,600 mg/m2 IV. Docetaxel + Herceptin phase: (Cycle length: 21 days.Total cycles: 4 cycles) Docetaxel, 100 mg/m2 IV, Herceptin (Produced by Roche) 8 mg/kg IV loading dose (at cycle 1), followed by 6 mg/kg at subsequent cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Farhad Shahi
Street address
Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
66581593
Phone
+98 21 6658 1593
Email
fshahi@yahoo.com

2

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mojtaba Ghadyani
Street address
District 3, Tehran, St, No. 207, Iran.
City
Tehran
Province
Tehran
Postal code
8805435
Phone
+98 21 8805 0435
Email
ghadianymojtaba@yahoo.com

3

Recruitment center
Name of recruitment center
Mehrad Hospital
Full name of responsible person
Jahangir Raafat
Street address
Miremad St. Mottahari St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
88747401
Phone
+98 21 8874 7401
Email
jahangirraafat@yahoo.com

4

Recruitment center
Name of recruitment center
Hazrate Rasool hospital
Full name of responsible person
Nafiseh Ansarinejad
Street address
Niyayesh St., Satarkhan St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
66515000
Phone
+98 21 6651 5000
Email
naffisse@yahoo.com

5

Recruitment center
Name of recruitment center
Park clinic
Full name of responsible person
Bahjat Kalantari
Street address
Sadi St, Kerman, Kerman Provinc, Iran
City
Kerman
Province
Kerman
Postal code
477801
Phone
+98 34 3226 5003
Email
dkalantarikhandani@gmail.com

6

Recruitment center
Name of recruitment center
Booali Hospital
Full name of responsible person
Arash Jenabian
Street address
Imam Hossein Square, Beginning Damavand Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
336055
Phone
+98 21 3333 6055
Email
arash_jenabian@yahoo.com

7

Recruitment center
Name of recruitment center
Javad-al-aeme Hospital
Full name of responsible person
Vahid Moazed
Street address
aboozar 25, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
18266
Phone
+98 34 3251 8266
Email
Moazed_vahid@yahoo.com

8

Recruitment center
Name of recruitment center
Shahid faqihi Hospital
Full name of responsible person
Shirin Haqiqatjoo
Street address
District 6, Shiraz, Fars Province, Iran
City
Shiraz
Province
Fars
Postal code
304905
Phone
+98 71 3230 4905
Email
haghighatjoo.sh@gmail.com

9

Recruitment center
Name of recruitment center
Sheikh Mofid (Alzahra) Clinic
Full name of responsible person
Ali Hajiqolami
Street address
Sheikh mofis St, Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
40219
Phone
+98 31 1224 0219
Email
ali_hajigholami@yahoo.com

10

Recruitment center
Name of recruitment center
Baqaie 2 Hospital
Full name of responsible person
Mehran Hosseinzadeh
Street address
Golestan St, Ahvaz, Khuzestan,
City
Ahvaz
Province
Khouzestan
Postal code
67543
Phone
+98 61 1336 7543
Email
hoseinzadehmehran@gmail.com

11

Recruitment center
Name of recruitment center
Toos Hospital
Full name of responsible person
Mohsen Razavi
Street address
Sanaie St., Motaharri St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
37902
Phone
+98 21 8893 7902
Email
s_m_raz@yahoo.com

12

Recruitment center
Name of recruitment center
Jahad daneshgahi center
Full name of responsible person
Safa Najjar Najafi
Street address
No. 45, West Shahid Nazari St. Aboureyhan St., Enghelab St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
66404050
Phone
+98 21 6640 4050
Email
safa3n@icbc.ir

13

Recruitment center
Name of recruitment center
Iran Masoud clinic
Full name of responsible person
Masoud Iravani
Street address
19th street, Amirabad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
747401
Phone
+98 21 8874 7401
Email
iravani_m@yahoo.com

14

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Abolghasem Allahyari
Street address
Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
430311
Phone
+98 51 8543 0311
Email
allahyari.abolghasem@yahoo.com

15

Recruitment center
Name of recruitment center
Dr. Mortazavi Zadeh Clinic
Full name of responsible person
Mohammad Reza Mortazavi Zade
Street address
No. 25, Shahid haj Mohammadi Alley, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
7250044
Phone
+98 35 3725 0044
Email
mortazavizadeh@yahoo.com

16

Recruitment center
Name of recruitment center
Aliebn Abitaleb Hospital
Full name of responsible person
Mahdi Hashemi
Street address
Dr. hesabi sq. Salamat Blvd, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
411260
Phone
+98 54 1341 1260
Email
Hashemimahdi@zuams.ac.ir

17

Recruitment center
Name of recruitment center
Dr. Payandeh Clinic
Full name of responsible person
Mehrdad Payandeh
Street address
No 101, Fakhr Razi Alley, Shahrdari square, Modares St., Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
282400
Phone
+98 83 3728 2400
Email
md.payande@yahoo.com

18

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Bayazid Qaderi
Street address
Pataran Ave., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
286112
Phone
+98 87 1328 6112
Email
bayazidg@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Aryogen pharmed Company
Full name of responsible person
Amir Farshchi
Street address
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co.
City
Tehran
Province
Tehran
Postal code
3164819711
Phone
+98 26 3610 6480
Fax
Email
contact@aryogen.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aryogen pharmed 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 department manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahrak gharb- Farahzadi Blvd., West Dadman Blvd.,derakhti St,-Khorasan- dead end i, No. 2
City
Tehran
Province
Tehran
Postal code
88821
Phone
+98 21 8808 8821
Fax
Email
Amini.s@orchidpharmed.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Safaie Nodehi
Position
principal investigator
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Keshavarz Blvd., Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
350649
Phone
+98 21669350649
Fax
Email
safano1334@gmail.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
Clinical Research Organization
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahrak gharb- Farahzadi Blvd., West Dadman Blvd.,derakhti St,-Khorasan- dead end i, No. 2
City
Tehran
Province
Tehran
Postal code
63546
Phone
+98 21 8808 8821
Fax
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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