Trials / Unknown
UnknownNCT03104010
A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD
A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD, preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence for the medication dosage in Phase 2 clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Somatropin Injection | Recombinant human growth hormone injection, 15IU/5mg/3ml/bottle. The first stage , 0.17mg/d(0.5IU/d), subcutaneous injection ,daily, 26weeks. The second stage(extension period study), 0.17mg/d(0.5IU/d), maximum ≤0.68mg/d (2IU/w),52 weeks. |
Timeline
- Start date
- 2017-04-01
- Primary completion
- 2022-02-01
- Completion
- 2022-09-01
- First posted
- 2017-04-07
- Last updated
- 2017-04-07
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03104010. Inclusion in this directory is not an endorsement.