NCT06103513

Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children

A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Growth Disorders
• Growth Failure
• Growth Hormone Treatment
• Growth

Interventions

Type	Name	Description
DRUG	Somatropin	The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.

Timeline

• Start date: 2023-12-10
• Primary completion: 2025-06-10
• Completion: 2025-12-10
• First posted: 2023-10-26
• Last updated: 2023-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study