Trials / Unknown
UnknownNCT03189160
A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome
A Phase 2 Study of Pegylated Recombinant Human Growth Hormone Injection to Treat Children of Turner Syndrome
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children of Turner syndrome (TS), preliminarily evaluate its safety and efficacy and provide scientific and reliable evidence for the medication dosage in Phase 3 clinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PEG-rhGH low dose | PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks. |
| BIOLOGICAL | PEG-rhGH high dose | PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks. |
| OTHER | Non-treatment control group |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2018-03-01
- First posted
- 2017-06-16
- Last updated
- 2017-12-12
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03189160. Inclusion in this directory is not an endorsement.