Growth hormone deficiency in children
Conditions
Interventions
[Investigational product]
JR-142
0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection
[Comparatar product]
INN: Somatropin (genetical recombination)
0.175 mg/kg/week, daily subcutaneous i
Sponsors
Hasegawa Masahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A pediatric patient who has not developed their puberty at the time of the first dose (A pediatric patient who is at Tanner Stage 1) 2) A male aged from 3 years to 10 years and 6 months and a female aged from 3 years to 9 years at the time of the first dose 3) A pediatric patient with -2.0 or less height SDS for chronological age at the time of screening test and the first dose
Exclusion criteria
Exclusion criteria: 1) A pediatric patient who have previously been treated with GH 2) A pediatric patient treated with adrenocortical hormone preparations, anabolic steroid preparations, thyroid hormone preparations, androgen preparations, follicular hormone preparations, luteinizing hormone preparations, Gn-RH derivatives, and IGF-1 preparations that may affect growth promotion within 24 months prior to screening test (for adrenocortical hormone preparations, excluding topical preparations and the use for not more than 1 week consecutively) 3) A pediatric patient with diseases causing short stature other than pediatric GHD (endocrine disorders, chromosomal abnormalities, malformation syndromes, bone system diseases, etc.) 4) A pediatric patient with a diagnosis of diabetes (following the Diagnostic Procedure for Diabetes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height SDS for chronological age from baseline (after 26 weeks) | — |
Contacts
Public ContactMasahiro Hasegawa
JCR Pharmaceuticals Co., Ltd.
Outcome results
None listed