Trials / Unknown
UnknownNCT03221088
A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Idiopathic Short Stature: A Controlled, Prospective, Randomized, Multicenter Phase-II Study With An Untreated Control Group.
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 4 Years – 9 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 with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Jintrolong® low dose group | PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks. |
| DRUG | Jintrolong® high dose group | PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks. |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2018-12-01
- First posted
- 2017-07-18
- Last updated
- 2017-07-19
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03221088. Inclusion in this directory is not an endorsement.