Trials / Unknown
UnknownNCT03290235
Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,500 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 42 Months – 15 Years
- Healthy volunteers
- Not accepted
Summary
1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG-somatropin | Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2020-10-01
- Completion
- 2021-09-01
- First posted
- 2017-09-21
- Last updated
- 2017-12-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03290235. Inclusion in this directory is not an endorsement.