Randomized clinical trial of two different initial growth hormone doses in children
Randomized clinical trial of two different initial growth hormone doses in children
ClinicalTrials.gov ID: NCT06103513
Sponsor: Northwell Health
Information provided by: Northwell Health (Responsible Party)
Last Update Posted: 2023-12-13
Brief Summary:
A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
Detailed Description:
Investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
Official Title:
A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
Intervention / Treatment:
- Drug: Somatropin
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-12-10
|
| Primary Completion (Estimated) |
2025-06-10
|
| Study Completion (Estimated) |
2025-12-10
|
| Enrollment (Estimated) | 50 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
23-0027
|