Trials / Unknown
UnknownNCT03554031
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome
A Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 1 Month – 5 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effectiveness of rhGH (Recombinant human growth hormone) injection for improving motor development in patients with PWS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human Growth Hormone (rhGH) Injection | Drug: Recombinant Human Growth Hormone Injection /Jintropin AQ, 30IU/10 mg/3ml/kit, 0.5 mg/m2/d for the first 4 weeks, then 1.0 mg/m2/d for subsequent 48 weeks; by subcutaneous injection, once per day for total 52 weeks. |
Timeline
- Start date
- 2018-04-14
- Primary completion
- 2020-01-01
- Completion
- 2020-01-01
- First posted
- 2018-06-12
- Last updated
- 2018-06-12
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03554031. Inclusion in this directory is not an endorsement.