Trials / Withdrawn
WithdrawnNCT03353454
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat (SHP625) in the Treatment of Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Mirum Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Maralixibat | Maralixibat oral solution (up to 600 mcg/kg) orally twice daily for 26 weeks. |
| DRUG | Placebo | Placebo matching to maralixibat orally twice daily for 26 weeks. |
Timeline
- Start date
- 2018-10-25
- Primary completion
- 2020-06-15
- Completion
- 2020-06-15
- First posted
- 2017-11-27
- Last updated
- 2019-03-18
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03353454. Inclusion in this directory is not an endorsement.