Protocol summary
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Study aim
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Efficacy and safety assessment of AryaTinaGen recombinant Growth Hormone, in comparison with Norditropin in growth hormone deficient children
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Design
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Parallel non-inferiority phase III, randomized clinical trial
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group: Biosimilar recombinant growth hormone (Somatin) 35 µg/kg/d, subcutaneous injection.
Control group: Norditropin recombinant growth hormone 35 µg/kg/d, subcutaneous injection
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Main outcome variables
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Height velocity in the first year after treatment
General information
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Reason for update
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Changes because of the food and drug administration requirements, updating recruitment centers and actual recruitment dates
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Acronym
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IRCT registration information
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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
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Registration date
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2019-03-05, 1397/12/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-05, 1398/02/15
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Expected recruitment end date
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2020-03-05, 1398/12/15
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Actual recruitment start date
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2020-05-19, 1399/02/30
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Actual recruitment end date
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2021-03-16, 1399/12/26
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Trial completion date
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empty
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Scientific title
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ِ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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Public title
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ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 2 years old to 11 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Outcome assessor
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-30, 1397/11/10
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.854
2
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Ethics committee
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Approval date
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2018-11-13, 1397/08/22
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Ethics committee reference number
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IR.GOUMS.REC.1397.173
Health conditions studied
1
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Description of health condition studied
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Short stature due to endocrine disorder
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ICD-10 code
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E34.3
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ICD-10 code description
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Short stature due to endocrine disorder
Primary outcomes
1
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Description
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Body height
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Timepoint
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Before treatment and 3, 6, 9 and 12 months later
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Method of measurement
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Using harpenden wall mounted stadiometer
Secondary outcomes
1
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Description
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Insulin-Like Growth Factor 1 serum level
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Timepoint
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Before treatment and 6 and 12 months later
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Method of measurement
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Hematology lab test
2
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Description
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Insulin-like growth factor-binding protein 3 serum level
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Timepoint
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Before treatment and 6 and 12 months later
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Method of measurement
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Hematology lab test
3
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Description
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bone age wrist
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Timepoint
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Before treatment and 12 months later
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Method of measurement
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Left wrist x-ray
4
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Description
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Weight
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Timepoint
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Before treatment and 3,6,9 and 12 months later
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Method of measurement
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Scale
Intervention groups
1
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Description
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Intervention group: AryaTinaGen recombinant Growth Hormone, 35µg/kg/d, subcutaneous injection
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Category
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Treatment - Drugs
2
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Description
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Control group: Norditropin recombinant Growth Hormone 35 µg/kg/d, subcutaneous injection
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arya Tina Gene company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available