Trials / Unknown
UnknownNCT06024967
A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency
The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
Detailed description
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG-somatropin | PEG-somatropin |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2025-05-01
- Completion
- 2025-09-01
- First posted
- 2023-09-06
- Last updated
- 2023-09-11
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06024967. Inclusion in this directory is not an endorsement.