Trials / Completed
CompletedNCT04697381
Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS
A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 0 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open label, multi cohort study to evaluate the efficacy and safety of somatropin in a cohort of Japanese participants with PWS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | somatropin - GH naïve pediatric cohort | somatropin 0.245 mg/kg/week |
| BIOLOGICAL | somatropin - GH treated cohort | somatropin 0.084 mg/kg/week |
| BIOLOGICAL | somatropin - adult cohort | somatropin 0.084 mg/kg/week |
Timeline
- Start date
- 2021-02-09
- Primary completion
- 2022-12-06
- Completion
- 2024-04-15
- First posted
- 2021-01-06
- Last updated
- 2026-01-14
- Results posted
- 2024-06-05
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04697381. Inclusion in this directory is not an endorsement.