A study to investigate the safety and efficacy of once-weekly PEG-somatropin (GenSci004) in children with growth hormone deficiency (ESCALATE)
A study to investigate the safety and efficacy of once-weekly PEG-somatropin (GenSci004) in children with growth hormone deficiency (ESCALATE)
ClinicalTrials.gov ID: NCT06024967
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Information provided by: Changchun GeneScience Pharmaceutical Co., Ltd. (Responsible Party)
Last Update Posted: 2023-09-11
Brief 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.
Official Title:
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
Intervention / Treatment:
- Drug: PEG-somatropin
| Category | Value |
|---|---|
| Study Start (Estimated) |
2023-12-01
|
| Primary Completion (Estimated) |
2025-05-01
|
| Study Completion (Estimated) |
2025-09-01
|
| Enrollment (Estimated) | 180 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
GenSci004-302
|