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.
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Protocol summary
Parallel non-inferiority phase III, randomized clinical trial
Parallel equivalency phase III, randomized clinical trial
Parallel non-inferiorityequivalency phase III, randomized clinical trial
کارآزمایی بالینی تصادفی شده، فاز 3، دو بازو، موازی به شکل noninferiority
کارآزمایی بالینی Equivalency، تصادفی شده، فاز 3، دو بازو، موازی
کارآزمایی بالینی Equivalency، تصادفی شده، فاز 3، دو بازو، موازی به شکل noninferiority
General information
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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
This change will be done according to the request of the sponsor and the approval of the Food and Drug Administration
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با توجه به درخواست اسپانسر و موافقت سازمان غذا دارو این تغییر انجام می گردد
با توجه به درخواست اسپانسر و موافقت سازمان غذا دارو این تغییر انجام می گردد
Efficacy and safety assessment of AryaTinaGen recombinant Growth Hormone, in comparison with Norditropin for increasing the growth rate, in GH deficiency children.
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.
EfficacyA phase III randomized parallel clinical trial to determine Equivalency therapeutic safety and safety assessment of AryaTinaGen recombinant Growth Hormone,efficacy between Somatin® (AryaTinaGene) and Norditropin® (Novonordisk) in comparisonpaediatrics with Norditropin for increasing the growth rate, in GH deficiency childrenhormone deficits.
بررسی اثربخشی و ایمنی هورمون رشد نوترکیب تولید شده در شرکت دانش بنیان آریاتیناژن در مقایسه با هورمون رشدNorditropin در افزایش میزان رشد در کودکان دچار نقص هورمون رشد.
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
بررسیبررس ی اثربخشی و ایمنی هورمون رشد نوترکیبسوماتین تولید شده در شرکت دانش بنیان آریاتیناژن در مقایسهدرمقایسه با هورمون رشدNorditropin در افزایش میزان رشد Norditropin در کودکان دچار نقص هورمون رشد.: مطالعه Equivalencyتصادفی شده، موازی
Protocol summary
Study aim
Efficacy and safety assessment of AryaTinaGen recombinant Growth Hormone, in comparison with Norditropin for increasing the growth rate, in GH deficiency children
Design
Parallel equivalency 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.
This change will be done according to the request of the sponsor and the approval of the Food and Drug Administration
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037571N1
Registration date:2019-03-05, 1397/12/14
Registration timing:prospective
Last update:2021-11-11, 1400/08/20
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
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Actual recruitment end date
empty
Trial completion date
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Scientific title
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.
Public title
Effect of AryaTinaGen recombinant Growth Hormone for increasing the growth rate
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
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
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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