drugset / Trial / NCT03353454
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2018-10-25
- Primary completion
- 2020-06-15
- Completion
- 2020-06-15
Outcome
Outcome not reported
Stopped: “The study was withdrawn due to change of ownership of the study drug maralixibat. Future studies of maralixibat will be posted by Mirum Pharmaceuticals.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maralixibat | Small molecule | 600 ug/kg | Oral |