Trials / Unknown
UnknownNCT03635580
Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS
Phase 2 Study of Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS (Idiopathic Short Stature): a 52-week Multicenter, Open-label, Randomized, Negative Controlled Study Followed by a 52-week Open-label Period
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 4 Years – 10 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks. Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Negative control | Untreated-control group |
Timeline
- Start date
- 2018-06-11
- Primary completion
- 2021-10-01
- Completion
- 2021-10-30
- First posted
- 2018-08-17
- Last updated
- 2018-08-17
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03635580. Inclusion in this directory is not an endorsement.