ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency: A non-inferiority phase III randomized parallel clinical trial
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Protocol summary
Efficacy and safety assessment of AryaTinaGen recombinant Growth Hormone, in comparison with Norditropin for increasing the growth rate, in GH deficiency children
Efficacy and safety assessment of AryaTinaGen recombinant Growth Hormone, in comparison with Norditropin in growth hormone deficient children
Efficacy and safety assessment of AryaTinaGen recombinant Growth Hormone, in comparison with Norditropin for increasing thein growth rate, in GH deficiencyhormone deficient children
Parallel equivalency phase III, randomized clinical trial
Parallel non-inferiority phase III, randomized clinical trial
Parallel equivalencynon-inferiority phase III, randomized clinical trial
کارآزمایی بالینی Equivalency، تصادفی شده، فاز 3، دو بازو، موازی
کارآزمایی بالینی non-inferiority، تصادفی شده، فاز 3، دو بازو، موازی
کارآزمایی بالینی Equivalencynon-inferiority، تصادفی شده، فاز 3، دو بازو، موازی
این مطالعه بر روی کودکان مبتلا به کمبود هورمون رشد مراجعه كننده در 10 مرکز بیمارگیری واقع در 14 شهر (تهران، گرگان، مشهد، تبریز، اصفهان، رشت، بابل، ساری، کرمان، اهواز، کرج، شیراز، قزوین و کرمانشاه) انجام خواهد شد. مرکز بیمارگیری اصلی بیمارستان طالقانی شهر گرگان است. پس از ورود بیمار به مطالعه بر اساس معیارهای ورود و عدم ورود و تکمیل فرم رضایت آگاهانه، آزمایشات و بررسیهای بالینی اولیه (شامل آزمایشات هماتولوژی و بیوشیمی و همچنان گرافی مچ دست) برای بیماران انجام شده و و اندازه های مربوط ثبت می گردد. سپس بیماران بر اساس لیست راندومیزاسون در یکی از دو گروه مداخله یا کنترل قرار می گیرند پس از انجام تزریق اول، اندازه گیری های مربوط تکرار می شود. رخدادهای نامطلوب احتمالی همراه با زمان رخداد، شدت و مدت زمان بهبود آنها نیز ثبت می گیرد. در هر دو گروه بیماران هر سه ماه یک بار تحت معاینات بالینی و تست های آزمایشگاهی قرار می گیرند.
این مطالعه بر روی کودکان مبتلا به کمبود هورمون رشد مراجعه كننده در 13 مرکز بیمارگیری واقع در 12 شهر (تهران، گرگان، مشهد، تبریز، اصفهان، رشت، بابل، کرمان، کرج، شیراز، قزوین و کرمانشاه) انجام خواهد شد. مرکز بیمارگیری اصلی بیمارستان طالقانی شهر گرگان است. پس از ورود بیمار به مطالعه بر اساس معیارهای ورود و عدم ورود و تکمیل فرم رضایت آگاهانه، آزمایشات و بررسیهای بالینی اولیه (شامل آزمایشات هماتولوژی و بیوشیمی و همچنان گرافی مچ دست) برای بیماران انجام شده و و اندازه های مربوط ثبت می گردد. سپس بیماران بر اساس لیست راندومیزاسون در یکی از دو گروه مداخله یا کنترل قرار می گیرند پس از انجام تزریق اول، اندازه گیری های مربوط تکرار می شود. رخدادهای نامطلوب احتمالی همراه با زمان رخداد، شدت و مدت زمان بهبود آنها نیز ثبت می گیرد. در هر دو گروه بیماران هر سه ماه یک بار تحت معاینات بالینی و تست های آزمایشگاهی قرار می گیرند.
این مطالعه بر روی کودکان مبتلا به کمبود هورمون رشد مراجعه كننده در 1013 مرکز بیمارگیری واقع در 1412 شهر (تهران، گرگان، مشهد، تبریز، اصفهان، رشت، بابل، ساری، کرمان، اهواز، کرج، شیراز، قزوین و کرمانشاه) انجام خواهد شد. مرکز بیمارگیری اصلی بیمارستان طالقانی شهر گرگان است. پس از ورود بیمار به مطالعه بر اساس معیارهای ورود و عدم ورود و تکمیل فرم رضایت آگاهانه، آزمایشات و بررسیهای بالینی اولیه (شامل آزمایشات هماتولوژی و بیوشیمی و همچنان گرافی مچ دست) برای بیماران انجام شده و و اندازه های مربوط ثبت می گردد. سپس بیماران بر اساس لیست راندومیزاسون در یکی از دو گروه مداخله یا کنترل قرار می گیرند پس از انجام تزریق اول، اندازه گیری های مربوط تکرار می شود. رخدادهای نامطلوب احتمالی همراه با زمان رخداد، شدت و مدت زمان بهبود آنها نیز ثبت می گیرد. در هر دو گروه بیماران هر سه ماه یک بار تحت معاینات بالینی و تست های آزمایشگاهی قرار می گیرند.
Inclusion criteria of the study is short stature defined as children who have
height standard deviation score (HSDS) < −3SD,
Exclusion criteria are hypothyroidism, celiac, seizure, , any chronic systemic disorders such as diabetes mellitus , sleep apnea syndrome, pervious GH replacement therapy, and concomitant use of corticosteroid.
Inclusion criteria of the study is short stature defined as children who have
height standard deviation score (HSDS) < −3SD,
Exclusion criteria are hypothyroidism, celiac, seizure, , any chronic systemic disorders such as diabetes mellitus , sleep apnea syndrome, pervious GH replacement therapy, and concomitant use of corticosteroid.
Inclusion criteria of the study is short stature defined as children who have height standard deviation score (HSDS) < −3SD, Exclusion criteria are hypothyroidism, celiac, seizure, , any chronic systemic disorders such as diabetes mellitus , sleep apnea syndrome, pervious GH replacement therapy, and concomitant use of corticosteroid.
گروه مداخله: داروی ایرانی PrhGH با دوز (µg/kg/d ) 35 برای بیماران به روش زیر جلدی
در گروه کنترل : درمان با استفاده از دوز (µg/kg/d ) 35 هورمون رشد نوترکیب شرکت نوو نوردیسک روزانه و به روش زيرجلدی
گروه مداخله: داروی ایرانی هورمون رشد نوترکیب سوماتین با دوز (µg/kg/d ) 35 برای بیماران به روش زیر جلدی
در گروه کنترل : درمان با استفاده از دوز (µg/kg/d ) 35 هورمون رشد نوترکیب شرکت نوو نوردیسک روزانه و به روش زيرجلدی
گروه مداخله: داروی ایرانی PrhGHهورمون رشد نوترکیب سوماتین با دوز (µg/kg/d ) 35 برای بیماران به روش زیر جلدی در گروه کنترل : درمان با استفاده از دوز (µg/kg/d ) 35 هورمون رشد نوترکیب شرکت نوو نوردیسک روزانه و به روش زيرجلدی
General information
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2020-05-19, 1399/02/30
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2021-03-16, 1399/12/26
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This change will be done according to the request of the sponsor and the approval of the Food and Drug Administration
Changes because of the food and drug administration requirements, updating recruitment centers and actual recruitment dates
This change will be done according to the requestChanges because of the sponsorfood and the approval of the Fooddrug administration requirements, updating recruitment centers and Drug Administrationactual recruitment dates
با توجه به درخواست اسپانسر و موافقت سازمان غذا دارو این تغییر انجام می گردد
تغییر به علت الزامات سازمان غذا دارو، بروزرسانی مراکز بیمارگیری و تاریخهای بیمارگیری تحقق یافته
با توجهتغییر به درخواست اسپانسر و موافقتعلت الزامات سازمان غذا دارو این تغییر انجام می گردد، بروزرسانی مراکز بیمارگیری و تاریخهای بیمارگیری تحقق یافته
Effect of AryaTinaGen recombinant Growth Hormone for increasing the growth rate
ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency
EffectِDetermining efficacy and safety of AryaTinaGen recombinant Growth Hormone for increasing the growth ratehormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency
تاثیر هورمون رشد نوترکیب تولید شده در شرکت دانش بنیان آریاتیناژن در افزایش میزان رشد کودکان
بررسی اثر بخشی و ایمنی هورمون رشد نوترکیب SOMATIN تولید شده در شرکت دانش بنیان آریا تینازن در مقایسه با هورمون رشد Norditropin در کودکان دچار نقص هورمون رشد
تاثیربررسی اثر بخشی و ایمنی هورمون رشد نوترکیب SOMATIN تولید شده در شرکت دانش بنیان آریاتیناژنآریا تینازن در افزایش میزانمقایسه با هورمون رشد Norditropin در کودکان دچار نقص هورمون رشد
A phase III randomized parallel clinical trial to determine Equivalency therapeutic safety and efficacy between Somatin® (AryaTinaGene) and Norditropin® (Novonordisk) in paediatrics with growth hormone deficits.
ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency: A non-inferiority phase III randomized parallel clinical trial
ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency: A non-inferiority phase III randomized parallel clinical trial to determine Equivalency therapeutic safety and efficacy between Somatin® (AryaTinaGene) and Norditropin® (Novonordisk) in paediatrics with growth hormone deficits.
بررس ی اثربخشی و ایمنی هورمون رشد سوماتین تولید شده در شرکت دانش بنیان آریاتیناژن درمقایسه با هورمون رشد Norditropin در کودکان دچار نقص هورمون رشد: مطالعه Equivalencyتصادفی شده، موازی
بررسی اثر بخشی و ایمنی هورمون رشد نوترکیب SOMATIN تولید شده در شرکت دانش بنیان آریا تینازن در مقایسه با هورمون رشد Norditropin در کودکان دچار نقص هورمون رشد: مطالعه Non-inferiority، فاز 3 ، تصادفی شده، موازی
بررس ی اثربخشیبررسی اثر بخشی و ایمنی هورمون رشد سوماتیننوترکیب SOMATIN تولید شده در شرکت دانش بنیان آریاتیناژن درمقایسهآریا تینازن در مقایسه با هورمون رشد Norditropin در کودکان دچار نقص هورمون رشد: مطالعه EquivalencyتصادفیNon-inferiority، فاز 3 ، تصادفی شده، موازی
Secondary outcomes
#1
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Weight
Weight
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وزن
وزن
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Before treatment and 3,6,9 and 12 months later
Before treatment and 3,6,9 and 12 months later
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قبل از مداخله و 3، 6، 9 و 12 ماه بعد از آن
قبل از مداخله و 3، 6، 9 و 12 ماه بعد از آن
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Scale
Scale
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ترازو
ترازو
Recruitment centers
#1
Name of recruitment center - English: Taleghani children hospital in Gorgan
Name of recruitment center - Persian: بیمارستان کودکان طالقانی گرگان
Full name of responsible person - English: Hossein Zarei
Full name of responsible person - Persian: حسین زائری
Street address - English: Gorgan, Janbazan Blvd Taleghani children hospital
Street address - Persian: گرگان، بلوار جانبازان، بیمارستان اموزشی درمانی کودکان طالقانی
City - English: Gorgan
City - Persian: گرگان
Province: Golestan
Country: Iran (Islamic Republic of)
Postal code: 4979146595
Phone: +98 17 3222 7720
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Taleghani children hospital in Gorgan
Name of recruitment center - Persian: بیمارستان کودکان طالقانی گرگان
Full name of responsible person - English: Hossein Zaeri
Full name of responsible person - Persian: حسین زائری
Street address - English: Janbazan boulevard
Street address - Persian: بلوار جانبازان
City - English: Gorgan
City - Persian: گرگان
Province: Golestan
Country: Iran (Islamic Republic of)
Postal code: 4979146595
Phone: +98 17 3222 7720
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Taleghani children hospital in Gorgan Name of recruitment center - Persian: بیمارستان کودکان طالقانی گرگان Full name of responsible person - English: Hossein ZareiZaeri Full name of responsible person - Persian: حسین زائری Street address - English: Gorgan, Janbazan Blvd Taleghani children hospitalboulevard Street address - Persian: گرگان، بلوار جانبازان، بیمارستان اموزشی درمانی کودکان طالقانی City - English: Gorgan City - Persian: گرگان Province: Golestan Country: Iran (Islamic Republic of) Postal code: 4979146595 Phone: +98 17 3222 7720 Fax: Email: dr.zaeri@yahoo.com Web page address:
#2
Name of recruitment center - English: Imam Hossein children hospital
Name of recruitment center - Persian: بیمارستان کودکان امام حسین
Full name of responsible person - English: Dr. Mahin Hashemipoor
Full name of responsible person - Persian: دکتر مهین هاشمی پور
Street address - English: Imam Khomeini street
Street address - Persian: خیابان امام خمینی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 31 3386 6266
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Imam Hossein children hospital Name of recruitment center - Persian: بیمارستان کودکان امام حسین Full name of responsible person - English: Dr. Mahin Hashemipoor Full name of responsible person - Persian: دکتر مهین هاشمی پور Street address - English: Imam Khomeini street Street address - Persian: خیابان امام خمینی City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 31 3386 6266 Fax: Email: dr.zaeri@yahoo.com Web page address:
#3
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Dr. Peyman Eshraghi
Full name of responsible person - Persian: دکتر پیمان اشراقی
Street address - English: Ibn Sina street
Street address - Persian: خیابان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 51 3854 3031
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Imam Reza hospital Name of recruitment center - Persian: بیمارستان امام رضا Full name of responsible person - English: Dr. Peyman Eshraghi Full name of responsible person - Persian: دکتر پیمان اشراقی Street address - English: Ibn Sina street Street address - Persian: خیابان ابن سینا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 51 3854 3031 Fax: Email: dr.zaeri@yahoo.com Web page address:
#4
Name of recruitment center - English: Iranian clinic
Name of recruitment center - Persian: ساختمان پزشکان ایرانیان
Full name of responsible person - English: ِDr. Serajaddin Arefnia
Full name of responsible person - Persian: دکتر سراج الدین عارف نیا
Street address - English: 15th Edalat street
Street address - Persian: خیابان عدالت 15
City - English: Gorgan
City - Persian: گرگان
Province: Golestan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 17 3233 8388
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Iranian clinic Name of recruitment center - Persian: ساختمان پزشکان ایرانیان Full name of responsible person - English: ِDr. Serajaddin Arefnia Full name of responsible person - Persian: دکتر سراج الدین عارف نیا Street address - English: 15th Edalat street Street address - Persian: خیابان عدالت 15 City - English: Gorgan City - Persian: گرگان Province: Golestan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 17 3233 8388 Fax: Email: dr.zaeri@yahoo.com Web page address:
#5
Name of recruitment center - English: Children's hospital
Name of recruitment center - Persian: بیمارستان کودکان
Full name of responsible person - English: Dr. Robabeh Ghergherehchi
Full name of responsible person - Persian: دکتر ربابه قرقره چی
Street address - English: Sheshgelan street
Street address - Persian: خیابان ششگلان
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 41 3526 2255
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Children's hospital Name of recruitment center - Persian: بیمارستان کودکان Full name of responsible person - English: Dr. Robabeh Ghergherehchi Full name of responsible person - Persian: دکتر ربابه قرقره چی Street address - English: Sheshgelan street Street address - Persian: خیابان ششگلان City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 41 3526 2255 Fax: Email: dr.zaeri@yahoo.com Web page address:
#6
Name of recruitment center - English: Dr. Dalili's clinic
Name of recruitment center - Persian: مطب دکتر دلیلی
Full name of responsible person - English: Dr. Setila Dalili
Full name of responsible person - Persian: دکتر ستیلا دلیلی
Street address - English: No. 48, 161st street, Gilan boulevard
Street address - Persian: بلوار گیلان - خ ۱۶۱- پلاک ۴۸
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 13 3312 9091
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Dr. Dalili's clinic Name of recruitment center - Persian: مطب دکتر دلیلی Full name of responsible person - English: Dr. Setila Dalili Full name of responsible person - Persian: دکتر ستیلا دلیلی Street address - English: No. 48, 161st street, Gilan boulevard Street address - Persian: بلوار گیلان - خ ۱۶۱- پلاک ۴۸ City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 13 3312 9091 Fax: Email: dr.zaeri@yahoo.com Web page address:
#7
Name of recruitment center - English: Baran Clinic
Name of recruitment center - Persian: کلینیک باران
Full name of responsible person - English: Dr. Elham Maleki
Full name of responsible person - Persian: دکتر الهام ملکی
Street address - English: Jahad boulevard
Street address - Persian: بلوار جهاد
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7619817189
Phone: +98 34 3223 5543
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Baran Clinic Name of recruitment center - Persian: کلینیک باران Full name of responsible person - English: Dr. Elham Maleki Full name of responsible person - Persian: دکتر الهام ملکی Street address - English: Jahad boulevard Street address - Persian: بلوار جهاد City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7619817189 Phone: +98 34 3223 5543 Fax: Email: dr.zaeri@yahoo.com Web page address:
#8
Name of recruitment center - English: Mohamad Kermanshahi hospital
Name of recruitment center - Persian: بیمارستان محمد کرمانشاهی
Full name of responsible person - English: Dr. Mahmoud Ghasemi
Full name of responsible person - Persian: دکتر محمود قاسمی
Street address - English: Hilal-Ahmar intersection
Street address - Persian: چهار راه هلال احمر
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6713733135
Phone: +98 83 3721 8202
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Mohamad Kermanshahi hospital Name of recruitment center - Persian: بیمارستان محمد کرمانشاهی Full name of responsible person - English: Dr. Mahmoud Ghasemi Full name of responsible person - Persian: دکتر محمود قاسمی Street address - English: Hilal-Ahmar intersection Street address - Persian: چهار راه هلال احمر City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6713733135 Phone: +98 83 3721 8202 Fax: Email: dr.zaeri@yahoo.com Web page address:
#9
Name of recruitment center - English: Bahonar hospital
Name of recruitment center - Persian: بیمارستان باهنر
Full name of responsible person - English: Dr. Shahab Noorian
Full name of responsible person - Persian: دکتر شهاب نوریان
Street address - English: Azimieh three-way
Street address - Persian: سه راه عظیمیه
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 26 3250 9256
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Bahonar hospital Name of recruitment center - Persian: بیمارستان باهنر Full name of responsible person - English: Dr. Shahab Noorian Full name of responsible person - Persian: دکتر شهاب نوریان Street address - English: Azimieh three-way Street address - Persian: سه راه عظیمیه City - English: Karaj City - Persian: کرج Province: Alborz Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 26 3250 9256 Fax: Email: dr.zaeri@yahoo.com Web page address:
#10
Name of recruitment center - English: Imam Reza clinic
Name of recruitment center - Persian: درمانگاه امام رضا
Full name of responsible person - English: Dr. Hossein Moravej
Full name of responsible person - Persian: دکتر حسین مروج
Street address - English: Namazi square
Street address - Persian: میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ۱۴۷۳۴۷۱۳۴۸
Phone: +98 71 3647 4673
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Imam Reza clinic Name of recruitment center - Persian: درمانگاه امام رضا Full name of responsible person - English: Dr. Hossein Moravej Full name of responsible person - Persian: دکتر حسین مروج Street address - English: Namazi square Street address - Persian: میدان نمازی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: ۱۴۷۳۴۷۱۳۴۸ Phone: +98 71 3647 4673 Fax: Email: dr.zaeri@yahoo.com Web page address:
#11
Name of recruitment center - English: Qods hospital
Name of recruitment center - Persian: بیمارستان قدس
Full name of responsible person - English: Dr. Abdollah Didban
Full name of responsible person - Persian: دکتر عبداله دیدبان
Street address - English: Qods square
Street address - Persian: میدان قدس
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 28 3333 4807
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Qods hospital Name of recruitment center - Persian: بیمارستان قدس Full name of responsible person - English: Dr. Abdollah Didban Full name of responsible person - Persian: دکتر عبداله دیدبان Street address - English: Qods square Street address - Persian: میدان قدس City - English: Qazvin City - Persian: قزوین Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 28 3333 4807 Fax: Email: dr.zaeri@yahoo.com Web page address:
#12
Name of recruitment center - English: Eram Clinic
Name of recruitment center - Persian: ساختمان پزشکان ارم
Full name of responsible person - English: Dr. Hoseinali Kharazmi
Full name of responsible person - Persian: دکتر حسینعلی خوارزمی
Street address - English: North Golshahr street
Street address - Persian: خیابان گلشهر شمالی
City - English: Bandarabas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 76 3363 4345
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Eram Clinic Name of recruitment center - Persian: ساختمان پزشکان ارم Full name of responsible person - English: Dr. Hoseinali Kharazmi Full name of responsible person - Persian: دکتر حسینعلی خوارزمی Street address - English: North Golshahr street Street address - Persian: خیابان گلشهر شمالی City - English: Bandarabas City - Persian: بندرعباس Province: Hormozgan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 76 3363 4345 Fax: Email: dr.zaeri@yahoo.com Web page address:
#13
Name of recruitment center - English: Rasool Akram hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم
Full name of responsible person - English: Dr. Fahimeh Soheilipoor
Full name of responsible person - Persian: دکتر فهیمه سهیلی پور
Street address - English: Niayesh Street
Street address - Persian: خیابان نیایش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 8888 6350
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of recruitment center - English: Rasool Akram hospital Name of recruitment center - Persian: بیمارستان رسول اکرم Full name of responsible person - English: Dr. Fahimeh Soheilipoor Full name of responsible person - Persian: دکتر فهیمه سهیلی پور Street address - English: Niayesh Street Street address - Persian: خیابان نیایش City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 8888 6350 Fax: Email: dr.zaeri@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Arya Tina Gene company
Name of organization / entity - Persian: شرکت دارویی آریاتیناژن
Full name of responsible person - English: Mohammad Ali Afshari
Full name of responsible person - Persian: محمد علی افشاری
Street address - English: Unit 16 SouthWest, 4th Floor, No. 103, Medical Building, Shahid K.Shokrollah St, North Amirabad St.
Street address - Persian: خیابان کارگر شمالی، خیابان شکراله، پ103، واحد 16
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1413684399
Phone: +98 21 8863 1277
Fax:
Email: nfo@atgbio.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Arya Tina Gene company
Name of organization / entity - Persian: شرکت دارویی آریاتیناژن
Full name of responsible person - English: Mohammad Ali Afshari
Full name of responsible person - Persian: محمد علی افشاری
Street address - English: 1st floor, No. 3, 2nd dead end, Hamsian street, West Keshavarz boulevard
Street address - Persian: بلوار کشاورز غربی، خیابان شهید حمصیان، بنبست دوم، پلاک 3، طبقه اول
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1418753471
Phone: +98 21 6642 5137
Fax:
Email: info@atgbio.com
Web page address:
contact.organization_id: Name of organization / entity - English: Arya Tina Gene company Name of organization / entity - Persian: شرکت دارویی آریاتیناژن Full name of responsible person - English: Mohammad Ali Afshari Full name of responsible person - Persian: محمد علی افشاری Street address - English: Unit 16 SouthWest, 4th Floor1st floor, No. 1033, Medical Building2nd dead end, Shahid K.Shokrollah StHamsian street, North Amirabad St.West Keshavarz boulevard Street address - Persian: خیابان کارگر شمالیبلوار کشاورز غربی، خیابان شکرالهشهید حمصیان، پ103بنبست دوم، واحد 16پلاک 3، طبقه اول City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14136843991418753471 Phone: +98 21 8863 12776642 5137 Fax: Email: nfoinfo@atgbio.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamed Hosseini
Full name of responsible person - Persian: حامد حسینی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 23 th unit, 4th floor, No 1547, North Kargar Street,
Street address - Persian: خیابان کارگر شمالی، پلاک 1547، طبقه 4، واحد 23،
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417993337
Phone: +98 21 8896 3546
Mobile: +98 913 341 1750
Fax:
Email: hmdhosseini@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ayat Ahmadi
Full name of responsible person - Persian: آیت احمدی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 23rd unit, 4th floor, No 1547, North Kargar Street,
Street address - Persian: خیابان کارگر شمالی، پلاک 1547، طبقه 4، واحد 23،
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417993337
Phone: +98 21 8896 3546
Mobile: +98 912 312 0794
Fax:
Email: ayat1049@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hamed HosseiniAyat Ahmadi Full name of responsible person - Persian: حامد حسینیآیت احمدی Position - English: Associate professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 2 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 23 th23rd unit, 4th floor, No 1547, North Kargar Street, Street address - Persian: خیابان کارگر شمالی، پلاک 1547، طبقه 4، واحد 23، City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1417993337 Phone: +98 21 8896 3546 Mobile: +98 913 341 1750912 312 0794 Fax: Email: hmdhosseiniayat1049@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hossein Zarei
Full name of responsible person - Persian: حسین زائری
Position - English: assisstant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 88
Area of specialty/work title - English: Endocrinologist
Area of specialty/work title - Persian: غدد درون ریز و متابولیسم
Street address - English: Gorgan, Janbazan Blvd Taleghani children hospital
Street address - Persian: گرگان، بلوار جانبازان، بیمارستان اموزشی درمانی کودکان طالقانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4979146595
Phone: +98 17 3222 7720
Mobile: +98 911 355 4671
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hossein Zarei
Full name of responsible person - Persian: حسین زائری
Position - English: assisstant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 88
Area of specialty/work title - English: Endocrinologist
Area of specialty/work title - Persian: غدد درون ریز و متابولیسم
Street address - English: Taleghani children hospital, Janbazan Blvd, Gorgan
Street address - Persian: گرگان، بلوار جانبازان، بیمارستان اموزشی درمانی کودکان طالقانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4979146595
Phone: +98 17 3222 7720
Mobile: +98 911 355 4671
Fax:
Email: dr.zaeri@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hossein Zarei Full name of responsible person - Persian: حسین زائری Position - English: assisstant professor Position - Persian: استادیار Latest degree: sub_specialist Area of specialty/work: 88 Area of specialty/work title - English: Endocrinologist Area of specialty/work title - Persian: غدد درون ریز و متابولیسم Street address - English: GorganTaleghani children hospital, Janbazan Blvd Taleghani children hospital, Gorgan Street address - Persian: گرگان، بلوار جانبازان، بیمارستان اموزشی درمانی کودکان طالقانی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4979146595 Phone: +98 17 3222 7720 Mobile: +98 911 355 4671 Fax: Email: dr.zaeri@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aniseh Samadi
Full name of responsible person - Persian: انیسه صمدی
Position - English: Researcher
Position - Persian: پژوهشگر
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 23 th unit, 4th floor, No 1547, North Kargar Street
Street address - Persian: خیابان کارگر شمالی، پلاک 1547، طبقه 4، واحد 23
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417993337
Phone: +98 21 8896 3546
Mobile: +98 912 305 1408
Fax:
Email: aniseh_samadi@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aniseh Samadi
Full name of responsible person - Persian: انیسه صمدی
Position - English: Researcher
Position - Persian: پژوهشگر
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 23rd unit, 4th floor, No 1547, North Kargar Street
Street address - Persian: خیابان کارگر شمالی، پلاک 1547، طبقه 4، واحد 23
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417993337
Phone: +98 21 8896 3546
Mobile: +98 912 305 1408
Fax:
Email: aniseh_samadi@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Aniseh Samadi Full name of responsible person - Persian: انیسه صمدی Position - English: Researcher Position - Persian: پژوهشگر Latest degree: med_doctor Area of specialty/work: 30 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 23 th23rd unit, 4th floor, No 1547, North Kargar Street Street address - Persian: خیابان کارگر شمالی، پلاک 1547، طبقه 4، واحد 23 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1417993337 Phone: +98 21 8896 3546 Mobile: +98 912 305 1408 Fax: Email: aniseh_samadi@yahoo.com Web page address:
Protocol summary
Study aim
Efficacy and safety assessment of AryaTinaGen recombinant Growth Hormone, in comparison with Norditropin in growth hormone deficient children
Design
Parallel non-inferiority phase III, randomized clinical trial
Settings and conduct
This study will be performed on children with growth hormone deficiency in 10 centers located in 14 cities (Tehran, Gorgan, Mashhad, Tabriz, Isfahan, Rasht, Babol, Sari, Kerman, Ahvaz, Karaj, Shiraz, Qazvin and Kermanshah). the main recruitment center is Taleghani hospital in Gorgan. Patients will be recruited according to inclusion and exclusion and complete the informed consent form as well as initial examinations and lab tests (including, hematology and biochemistry tests and wrist x-ray). Then patients will fall into one of the two groups of intervention or control, based on the randomization list. After the first injection, the related measurements will be repeated. Possible adverse events will be also recorded. In both groups, patients undergo clinical examinations and laboratory tests every three months
Participants/Inclusion and exclusion criteria
Inclusion criteria of the study is short stature defined as children who have
height standard deviation score (HSDS) < −3SD,
Exclusion criteria are hypothyroidism, celiac, seizure, , any chronic systemic disorders such as diabetes mellitus , sleep apnea syndrome, pervious GH replacement therapy, and concomitant use of corticosteroid.
Changes because of the food and drug administration requirements, updating recruitment centers and actual recruitment dates
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037571N1
Registration date:2019-03-05, 1397/12/14
Registration timing:prospective
Last update:2022-09-13, 1401/06/22
Update count:2
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Hamed Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
hmdhosseini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
2020-05-19, 1399/02/30
Actual recruitment end date
2021-03-16, 1399/12/26
Trial completion date
empty
Scientific title
ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency: A non-inferiority phase III randomized parallel clinical trial
Public title
ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children older than 2 and younger than 10 for girls and 11 for boys.
Short stature with height standard deviation score (HSDS) < −3SD,
No increase in growth hormone more than 10 or 20 mlU/L after fasting and clonidine stimulating test
Signing the written informed consent by the gradians and assent by children older than 7
Exclusion criteria:
Any history of using GH or history of using estrogen of adrenal androgens within last year.
History of seizure, sleep apnea syndrome or other respiratory disorders.
Concomitant use of corticosteroid
Any chronic systemic disorders such as hypothyroidism, DM, rickets, skeletal dysplasia, pervious chromosomal abnormalities
Sensitivity to GH
History of chemotherapy of radiotherapy
Children with psychosocial dwarfism or idiopathic or familial short stature
Children with idiopathic or familial short stature
Spinal disorders such as scoliosis, kyphosis, chiari malformation, spinabifida variations
Age
From 2 years old to 11 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random Chain Generation performed using by (https://www.sealedenvelope.com)We used randomized permutations, blocks (the size of each block is 4) for a total of 80 volunteers (1: 1 ratio). The codes will be labeled on the drugs. After ensuring the volunteer's eligibility and signing the informed consent form, a nurse will receive a code from the study site which will be used for random allocation of the drug to the candidate. The related drug will be used for the volunteer. In this way, the volunteers fall into one of the two intervention groups and the volunteers' group and the type of drug they receive will not be disclosed to researchers or the study team
Blinding (investigator's opinion)
Single blinded
Blinding description
In this clinical trial, blindness can not be fully accomplished (due to the brand's exclusive form of this drug, this is not possible for any study), but we try to minimize the information sources for different individuals in the study to prevent the Information bias. For this purpose, syringes containing both drugs are packaged with code only. Researchers who prescribe medication, those who provide the drug to patients, and those who are responsible for the examination and evaluation of patients, will be unaware of the nature of the syringes, and during this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.TUMS.VCR.REC.1397.854
2
Ethics committee
Name of ethics committee
Golestan University of Medical sciences
Street address
Hirkan Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4931171756
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.GOUMS.REC.1397.173
Health conditions studied
1
Description of health condition studied
Short stature due to endocrine disorder
ICD-10 code
E34.3
ICD-10 code description
Short stature due to endocrine disorder
Primary outcomes
1
Description
Body height
Timepoint
Before treatment and 3, 6, 9 and 12 months later
Method of measurement
Using harpenden wall mounted stadiometer
Secondary outcomes
1
Description
Insulin-Like Growth Factor 1 serum level
Timepoint
Before treatment and 6 and 12 months later
Method of measurement
Hematology lab test
2
Description
Insulin-like growth factor-binding protein 3 serum level