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a pilot study to Assess the therapeutics indicators in Patients With Acute Myeloid Leukemia Undergoing therapy With deferasirox in Afzalipour Hospital of Kerman

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History
# Registration date Revision Id
2 2022-06-28, 1401/04/07 233578
1 2021-05-08, 1400/02/18 181657
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  • Protocol summary

    Determining the clinical effect of deferoxamine on the treatment of AML
    Determining the clinical effect of deferasirox on the treatment of AML
    تعیین تاثیر بالینی داروی دفروکسامین بر روند درمان بیماری AML
    تعیین تاثیر بالینی داروی دفراسیروکس بر روند درمان بیماری AML
    This trial will be performed in the blood and oncology department of Shahid Bahonar Hospital in Kerman. Patients whose type of disease and prognosis will be determined and also meet the conditions for inclusion in the study will be randomly admitted to one of the two intervention groups. The doctor and the patients will be blind and patients will receive the desired intervention for 14 days. And then the primary and secondary variables will be evaluated on days 14 and 28 of the study
    This trial will be performed in the blood and oncology department of Afzalipour Hospital in Kerman. Patients whose type of disease and prognosis will be determined and also meet the conditions for inclusion in the study will be randomly admitted to one of the two intervention groups. The outcome assessor and the patients will be blind and patients will receive the desired intervention for 28 days. And then the primary and secondary variables will be evaluated on days 14 and 28 of the study
    این کارآزمایی در بخش خون و انکولوژی بیمارستان شهید باهنر کرمان انجام خواهد شد. بیمارانی که نوع بیماری و پیش آگهی ان مشخص شده است و همچنین شرایط ورود به مطالعه را احراز کنند.بصورت تصادفی در یکی از دو گروه مداخله وارد می شوند.پزشک و بیمار کورسازی شده اند و بیماران به مدت 14 روز مداخله مورد نظر را دریافت خواهند کرد و سپس متغیر های اولیه و ثانویه در روز 14و 28 مطالعه ارزیابی خواهند شد.
    این کارآزمایی در بخش خون و انکولوژی بیمارستان افضلی پور کرمان انجام خواهد شد. بیمارانی که نوع بیماری و پیش آگهی انان مشخص شده است و همچنین شرایط ورود به مطالعه را احراز کنند.بصورت تصادفی در یکی از دو گروه مداخله وارد می شوند.آنالیز کننده داده و بیمار کورسازی شده اند و بیماران به مدت 28 روز مداخله مورد نظر را دریافت خواهند کرد و سپس متغیر های اولیه و ثانویه در روز 14و 28 مطالعه ارزیابی خواهند شد.
    Control group: standard treatment. Intervention group: standard treatment with deferoxamine.
    Control group: standard treatment. Intervention group: standard treatment with deferasirox.
    دریافت درمان استاندارد برای گروه کنترل و دریافت درمان استاندارد با دفروکسامین برای گروه دیگر
    دریافت درمان استاندارد برای گروه کنترل و دریافت درمان استاندارد با دفراسیروکس برای گروه دیگر

  • General information

    1
    1
    2021-06-10, 1400/03/20
    2022-09-23, 1401/07/01
    2022-06-10, 1401/03/20
    2023-09-21, 1402/06/30
    empty
    - Change of study site: due to relocation of the hematology and oncology ward from Shahid Bahonar Hospital in Kerman to Afzalipour Hospital -change the form of the intervention drug: based on the necessity of the prophylactic antifungal drugs administration to prevent side effects of the interventional drug and the difficulty of obtaining these drugs due to the coronavirus pandemic caused conditions, to reduce the potential hazards of intervention, the intravenous form of the drug (deferoxamine) is replaced by the oral form of that (deferasirox). The request for this change has been approved by the University Ethics Committee, recently. -time of starting the Patient recruitment: minimizing the potential risks of intervention for patients because of the weakened immune condition caused by the course of treatment in the coronavirus pandemic duration, a long-term process of negotiation with study sponsors to fund it due to provide the necessary laboratory materials and equipment to evaluate the outcomes of the study has not been possible up to now And it is estimated that would be possible in the next few months. -Randomization: Due to the importance of patients' prognosis and its effect on the expected therapeutic response rate, the method of randomization was changed from simple to permuted block randomization. -Blinding: To optimize the level of concealment, we changed the blindness from physician to data analyst
    empty
    - تغییر مرکز مطالعه : بعلت جا به جایی بخش خون و سرطان از بیمارستان شهید باهنر کرمان به بیمارستان افضلی پور - تغییر فرم مصرفی داروی مداخله : بعلت الزام مصرف پیشگیرانه دارو های ضد قارچ جهت جلوگیری از عوارض جانبی دارو مداخله و صعب الحصول بودن این داروها بعلت شرایط بوجود آمده ناشی از همه گیری کرونا ، جهت کاهش مخاطرات احتمالی مداخله ، فرم وریدی دارو (دفروکسامین) با فرم خوراکی آن (دفراسیروکس) جایگزین گردیده است. درخواست این تغییر در کمیته اخلاق دانشگاه اخیرا تایید شده است. - تاریخ شروع بیمارگیری: بعلت به حداقل رساندن خطرات احتمالی مداخله برای بیماران با توجه به شرایط ایمنی تضعیف شده ناشی از دوره درمان در زمان همه گیری ویروس کرونا، زمان طولانی مذاکره با اسپانسرهای مطالعه جهت تامین بودجه آن و تهیه مواد و تجهیزات ازمایشگاهی لازم ارزیابی کننده پیامد های مطالعه تا کنون امکان شروع بیمارگیری میسر نشده است و تخمین زده میشود این امکان طی چند ماه آینده میسر شود. تصادفی سازی : بعلت اهمیت پیش آگهی بیماران و تاثیر آن در میزان پاسخ مورد انتظار نحوه تصادفی سازی از نوع ساده به permuted block randomization تغییر یافت. کورسازی: برای بهینه سازی سطح پنهان سازی مطالعه ،کورسازی از پزشک به فرد آنالیز کننده داده تغییر یافت.
    Evaluation the Effect of deferoxamine on the treatment of ََAcute myeloid leukemia
    Evaluation of the Effect of deferasirox on the treatment of ََAcute myeloid leukemia
    بررسی تاثیر دفروکسامین بر درمان لوسمی میلوئیدی حاد
    بررسی تاثیر دفراسیروکس بر درمان لوسمی میلوئیدی حاد
    Assess the therapeutics indicators in Patients With Acute Myeloid Leukemia Undergoing therapy With deferoxamine in Shahid Bahonar Hospital of Kerman
    a pilot study to Assess the therapeutics indicators in Patients With Acute Myeloid Leukemia Undergoing therapy With deferasirox in Afzalipour Hospital of Kerman
    مطالعه مقدماتی جهت ارزیابی شاخص های درمانی در بیماران مبتلا به لوسمی میلوئیدی حاد تحت درمان با دفروکسامین در بیمارستان شهید باهنر کرمان
    مطالعه مقدماتی جهت ارزیابی شاخص های درمانی در بیماران مبتلا به لوسمی میلوئیدی حاد تحت درمان با دفراسیروکس در بیمارستان افضلی پور کرمان
    Patients will be divided into two groups n = 20 (including dropout) by the statistical specialist of the project. According to the table of random numbers, the researcher considers even numbers for intervention group 1 and odd numbers for intervention group 2, then puts his hand on one of the numbers and moves upwards and records the numbers, and assigns the patients based on reference to different groups
    Patients divide into two groups n = 20 (including dropouts). Block permuted randomization method uses, based on that, patients organize in a three-level prognosis(A, B, C) in each three-person block of any interventional group. According to the random numbers chart, the researchers consider even numbers for the control group and odd numbers for the intervention group, then put their hand on one of the numbers and move upwards and record the numbers, and assign the patients based on that individual group
    بیماران توسط متخصص آماری طرح به دوگروه n=20 (با احتساب ریزش) مداخله ای تقسیم خواهند شد. با توجه به جدول اعداد تصادفی محقق اعداد زوج را براي گروه مداخله 1 و اعداد فرد براي گروه مداخلــه 2 درنظر می گیرد ،سپس برروي يكي از اعداد دست ميگذارد و در جهت بالا حركت كرده و اعداد را ثبت و بترتیب مراجعه بیماران، به گروههاي مختلف تخصيص مـيدهـد
    بیماران به دوگروه n=20 (با احتساب ریزش) تقسیم خواهند شد. از روش Block permuted randomization استفاده میشود و افراد براساس آن برای هر گروه سه نفره از هرگروه مداخله در سه سطح پیش آگهی سازماندهی میشوند. و با توجه به جدول اعداد تصادفی محقق اعداد زوج را براي گروه کنترل و اعداد فرد را براي گروه مداخلــه درنظر می گیرد ،سپس برروي يكي از اعداد دست ميگذارد و در جهت بالا حركت كرده و اعداد را ثبت و براساس آن، به گروه مشخص تخصيص مـيدهـد
    People will be kept blind. 1. Patients: Each patient will receive a label according to the random number table that will appear on the patient's drug package. 2. Physician: The analyzing team will give the medicine boxes to the physician, and the physician will provide the medication based on the random number table.
    People will be kept blind. Patient: Receives the intervention drug in combination with the daily meals outcome assessor: The information of each patient is provided to the analyzer team in an unidentifiable manner with unique codes. They are also not aware of the details of the study process.
    افراد زیر کور نگه داشته می شوند: بیمار: هر بیمار با توجه به جدول اعداد تصادفی یک برچسب بر روی بسته دارویی دریافت می کند. پزشک: تیم آنالیزکننده بسته دارویی را به پزشک خواهد داد و پزشک براساس جدول اعداد تصادفی داروها را برای بیمار فراهم خواهد کرد.
    افراد زیر کور نگه داشته می شوند: بیمار: داروی مداخله را بصورت ترکیب شده با وعده های غذایی روزانه دریافت میکند آنالیز کننده داده : اطلاعات هربیمار بصورت غیر قابل شناسایی و با کد های منحصر بفرد دراختیار فرد انالیزکننده قرار میگرد.و همچنین از جزییات روند مطالعه مطلع نیستند.

  • Intervention groups

    #1
    Intervention group: receive the standard treatment Cytarabine and idarubicin (7+3) with IV infusion of Deferoxamine 1000 mg for 8 to 12 hours daily at the first 14 days
    Intervention group: receive the standard treatment Cytarabine and idarubicin (7+3) with oral intake of Deferasirox capsule 360 mg daily for 28 days
    گروه مداخله: درمان استاندارد سیتارابین و ایداروبوسین (7+3) بهمراه داروی دفروکسامین انفوزیون وریدی 1000 میلی گرم به مدت زمان 8 الی 12 ساعت روزانه در 14روز نخست دریافت می کنند.
    گروه مداخله: درمان استاندارد سیتارابین و ایداروبوسین (7+3) بهمراه داروی دفراسیروکس کپسول خوراکی 360 میلی گرم روزانه یک عدد به مدت زمان28 روز دریافت می کنند.

  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Bahonar Hospital of Kerman
    Name of recruitment center - Persian: بیمارستان شهید باهنر کرمان
    Full name of responsible person - English: َAliasghar Tirgar
    Full name of responsible person - Persian: علی اصغر تیرگر
    Street address - English: Kerman Province, Kerman, Qaraney St
    Street address - Persian: کرمان- خیابان قرنی
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Country: Iran (Islamic Republic of)
    Postal code: 7616913555
    Phone: +98 34 3223 5011
    Fax: +98 34 3226 0100
    Email: maazed@kmu.ac.ir
    Web page address: http://bh.kmu.ac.ir/fa
    Name of recruitment center - English: Afzalipour Hospital of Kerman
    Name of recruitment center - Persian: بیمارستان افضلی پور کرمان
    Full name of responsible person - English: َAliasghar Tirgar
    Full name of responsible person - Persian: علی اصغر تیرگر
    Street address - English: Kerman Province, Kerman, Imam khomieni Highway
    Street address - Persian: کرمان- بزرگراه امام خمینی
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Country: Iran (Islamic Republic of)
    Postal code: 7616913555
    Phone: +98 34 3223 5011
    Fax: +98 34 3226 0100
    Email: maazed@kmu.ac.ir
    Web page address: https://ah.kmu.ac.ir/fa

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Aliasghar Tirgar
    Full name of responsible person - Persian: علی اصغر تیرگر
    Position - English: medical student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: no.14 , Alley 1 , shahidan ghotbi nezhad Ave, Azadegan Blvd, Kerman Town
    Street address - Persian: بلوار آزادگان-خیابان شهیدان قطبی نژاد-کوچه1-پلاک 14
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7619677886
    Phone: 0098342462413
    Mobile: +98 938 542 0531
    Fax:
    Email: a.tirgar@kmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Aliasghar Tirgar
    Full name of responsible person - Persian: علی اصغر تیرگر
    Position - English: Medical student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: no.14 , Alley 1 , shahidan ghotbi nezhad Ave, Azadegan Blvd, Kerman Town
    Street address - Persian: بلوار آزادگان-خیابان شهیدان قطبی نژاد-کوچه1-پلاک 14
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7619677886
    Phone: 0098342462413
    Mobile: +98 938 542 0531
    Fax:
    Email: a.tirgar@kmu.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Aliasghar Tirgar
    Full name of responsible person - Persian: علی اصغر تیرگر
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: no.14, Alley 1, Shahidan ghotbi nezhad Ave,Azadegan Blvd,Kerman Town
    Street address - Persian: کرمان-بلوار آزادگان-خیابان شهیدان قطبی نژاد-کوچه 1-پلاک 14
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7619677886
    Phone: +98 34 3246 2413
    Mobile: +98 938 542 0531
    Fax:
    Email: tirgar4@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Aliasghar Tirgar
    Full name of responsible person - Persian: علی اصغر تیرگر
    Position - English: Medical student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: no.14, Alley 1, Shahidan ghotbi nezhad Ave,Azadegan Blvd,Kerman Town
    Street address - Persian: کرمان-بلوار آزادگان-خیابان شهیدان قطبی نژاد-کوچه 1-پلاک 14
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7619677886
    Phone: +98 34 3246 2413
    Mobile: +98 938 542 0531
    Fax:
    Email: tirgar4@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the clinical effect of deferasirox on the treatment of AML
Design
a clinical trial with a control group with parallel, double-blind, randomized control groups, phase 3, on 40 patients, a random number table is used for randomization.
Settings and conduct
This trial will be performed in the blood and oncology department of Afzalipour Hospital in Kerman. Patients whose type of disease and prognosis will be determined and also meet the conditions for inclusion in the study will be randomly admitted to one of the two intervention groups. The outcome assessor and the patients will be blind and patients will receive the desired intervention for 28 days. And then the primary and secondary variables will be evaluated on days 14 and 28 of the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 -65 years; both gender; patients with AML/non-APL. Exclusion criteria: HIV infected patients or Hepatitis B, C patients; patients with AML-induced neurological involvement; patients with uncontrolled blood pressure and heart failure; patients with a history of ocular toxicity due to iron chelators.
Intervention groups
Control group: standard treatment. Intervention group: standard treatment with deferasirox.
Main outcome variables
The rate of apoptotic cells of CD34 + leukemia blasts; the rate of Reactive oxygen species in CD34+ leukemia blast: the percentage of leukemia blasts in AML patients after receiving treatment.

General information

Reason for update
- Change of study site: due to relocation of the hematology and oncology ward from Shahid Bahonar Hospital in Kerman to Afzalipour Hospital -change the form of the intervention drug: based on the necessity of the prophylactic antifungal drugs administration to prevent side effects of the interventional drug and the difficulty of obtaining these drugs due to the coronavirus pandemic caused conditions, to reduce the potential hazards of intervention, the intravenous form of the drug (deferoxamine) is replaced by the oral form of that (deferasirox). The request for this change has been approved by the University Ethics Committee, recently. -time of starting the Patient recruitment: minimizing the potential risks of intervention for patients because of the weakened immune condition caused by the course of treatment in the coronavirus pandemic duration, a long-term process of negotiation with study sponsors to fund it due to provide the necessary laboratory materials and equipment to evaluate the outcomes of the study has not been possible up to now And it is estimated that would be possible in the next few months. -Randomization: Due to the importance of patients' prognosis and its effect on the expected therapeutic response rate, the method of randomization was changed from simple to permuted block randomization. -Blinding: To optimize the level of concealment, we changed the blindness from physician to data analyst
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20200313046756N2
Registration date: 2021-05-08, 1400/02/18
Registration timing: prospective

Last update: 2022-07-16, 1401/04/25
Update count: 1
Registration date
2021-05-08, 1400/02/18
Registrant information
Name
Vahid Maazed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 1223 5019
Email address
maazed@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
a pilot study to Assess the therapeutics indicators in Patients With Acute Myeloid Leukemia Undergoing therapy With deferasirox in Afzalipour Hospital of Kerman
Public title
Evaluation of the Effect of deferasirox on the treatment of ََAcute myeloid leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years AML/non-APL
Exclusion criteria:
HIV infected patients or Hepatitis B,C patients Patients with AML-induced neurological involvement Patients with uncontrolled blood pressure and heart failure Patients with a history of ocular toxicity due to iron chelators drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients divide into two groups n = 20 (including dropouts). Block permuted randomization method uses, based on that, patients organize in a three-level prognosis(A, B, C) in each three-person block of any interventional group. According to the random numbers chart, the researchers consider even numbers for the control group and odd numbers for the intervention group, then put their hand on one of the numbers and move upwards and record the numbers, and assign the patients based on that individual group
Blinding (investigator's opinion)
Double blinded
Blinding description
People will be kept blind. Patient: Receives the intervention drug in combination with the daily meals outcome assessor: The information of each patient is provided to the analyzer team in an unidentifiable manner with unique codes. They are also not aware of the details of the study process.
Placebo
Not used
Assignment
Parallel
Other design features
one group receiving standard treatment(without placebo) and the other group receive the standard treatment and interventional drug

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Beginning of Ibn Sina Street, First of Jihad Boulevard, Somayeh intersection (Tahmasb Abad)
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-11-23, 1399/09/03
Ethics committee reference number
IR.KMU.REC.1399.482

Health conditions studied

1

Description of health condition studied
Acute myeloblastic leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia

Primary outcomes

1

Description
The number of white blood cells
Timepoint
on days 14 and 28
Method of measurement
Test for complete blood cell count

2

Description
Number of red blood cells
Timepoint
on days 14 and 28
Method of measurement
Test for complete blood cell count

3

Description
platelet numbers
Timepoint
on days 14 and 28
Method of measurement
Test for complete blood cell count

4

Description
Percentage of CD34 + leukemia blasts of bone marrow biopsy specimen
Timepoint
on days 14 and 28
Method of measurement
Flow cytometry with CD34 monoclonal antibody

Secondary outcomes

1

Description
Reactive oxygen species rate in +CD34 leukemic blasts bone marrow biopsy sample
Timepoint
on days 14 and 28
Method of measurement
Flow cytometry

2

Description
The rate of apoptotic cells in +CD34 leukemic blasts bone marrow biopsy sample
Timepoint
on days 14 and 28
Method of measurement
Flow cytometry

Intervention groups

1

Description
Intervention group: receive the standard treatment Cytarabine and idarubicin (7+3) with oral intake of Deferasirox capsule 360 mg daily for 28 days
Category
Treatment - Drugs

2

Description
Control group: receive the standard treatment Cytarabine and idarubicin (7+3) without Placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital of Kerman
Full name of responsible person
َAliasghar Tirgar
Street address
Kerman Province, Kerman, Imam khomieni Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3223 5011
Fax
+98 34 3226 0100
Email
maazed@kmu.ac.ir
Web page address
https://ah.kmu.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Kerman university of medical sciences,Medical University Campus,Haft-Bagh Highway,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Nano Fanavaran Alvand pharmaceutical co.
Full name of responsible person
Babak Yazdani
Street address
No. 485, Unit 52 Between 63 St & 65 St Yousef Abad St. Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8802 0579
Fax
+98 21 8802 0579
Email
info@nanoalvand.com
Web page address
http://www.nanoalvand.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nano Fanavaran Alvand pharmaceutical co.
Proportion provided by this source
30
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

3

Sponsor
Name of organization / entity
AryaTinaGene biopharmaceutical co.
Full name of responsible person
Behnam Taghavi
Street address
Second Sazandegi, Aq qalla Industrial state, Gorgon, Iran
City
Gorgan
Province
Golestan
Postal code
4931171756
Phone
+98 17 3453 3545
Fax
+98 17 3453 3545
Email
info@atgbio.com
Web page address
http://www.atgbio.com/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AryaTinaGene biopharmaceutical co.
Proportion provided by this source
30
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
Kerman University of Medical Sciences
Full name of responsible person
Aliasghar Tirgar
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
no.14 , Alley 1 , shahidan ghotbi nezhad Ave, Azadegan Blvd, Kerman Town
City
Kerman
Province
Kerman
Postal code
7619677886
Phone
0098342462413
Email
a.tirgar@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Vahid Moazed
Position
Associated Professor in Kerman University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
3 number Alley, Najafi Lary st., Jomhoori Islami Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619655598
Phone
+98 34 3244 2425
Email
Moazed_vahid@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Aliasghar Tirgar
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
no.14, Alley 1, Shahidan ghotbi nezhad Ave,Azadegan Blvd,Kerman Town
City
Kerman
Province
Kerman
Postal code
7619677886
Phone
+98 34 3246 2413
Email
tirgar4@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be initially de-identified. 1. Demographic Data of Participants: These data will generally be included in a table in the article. 2. Main outcome data: The article will be appended to the article in charts and tables as well as in an Excel file. Secondary outcome data in the article will be attached to the article in graphs and tables as well as in an Excel file.
When the data will become available and for how long
Starting data access period six months after the results are published
To whom data/document is available
Data will be available only to researchers working in academic and scientific institutions approved by the Ministry of Health
Under which criteria data/document could be used
The data will be available to researchers for further statistical analysis
From where data/document is obtainable
Refer to the person responsible for the project's scientific accountability to access the data
What processes are involved for a request to access data/document
Applicants will submit a personal resume and the purpose of the data to the person responsible for the scientific account of the plan. The responsible person will be required to investigate the request within one week of sending the researcher information
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