Growth hormone deficiency in children
Conditions
Interventions
Investigational product name: JR-401 (INN: somatropin)
Dosage and Administration: 0.175 mg/kg or 0.3 mg/kg, administered subcutaneously, divided into 7 doses per week
Sponsors
Utsunomiya Yuto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have not yet reached puberty at the time of screening (Tanner Stage 1) 2) Patients who are between 3 and 10 years of age for boys and between 3 and 8 years of age for girls at the time of the screening test 3) Patients whose calendar age equivalent height at the time of screening test and first dose is less than -2.0 SD of standard height or whose height is in the reference range but whose growth rate is less than -1.5 SD of standard value for more than 2 years
Exclusion criteria
Exclusion criteria: 1) Patients previously treated with GH preparations 2) Patients who have received concomitant treatment within 12 months prior to the screening test that may have an effect on growth promotion 3) Patients using inhaled steroids at doses greater than 400 ug/day of inhaled budesonide or its equivalent within 12 months prior to screening test 4) Patients with conditions other than pediatric GHD that cause short stature (e.g., endocrine disorders, chromosomal abnormalities, malformation syndromes, and bone system diseases) 5) Patients whose birth weight and height were below the 10th percentile for the corresponding number of weeks of gestation, and birth weight or height was less than the [standard value - 2SD] for the corresponding number of weeks of gestation 6) Patients diagnosed with diabetes mellitus and whose blood glucose is not controlled by diet and exercise therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height SDS for chronological age from the first administration (Week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in height SDS for chronological age from the first administration over time 2) Height SDS for chronological age over time 3) Change in growth velocity from the first administration 4) Growth velocity 5) Change in bone age from the first administration 6) Bone age 7) Bone age SDS for chronological age over time 8) Bone age relative to chronological age 9) Ratio of change in bone age relative to change in chronological age 10) Change in serum Insulin-like Growth Factor-1 (IGF-1) SDS from the first administration | — |
Contacts
Public ContactYuto Utsunomiya
JCR Pharmaceuticals Co., Ltd.
Outcome results
None listed