drugset / Trial / NCT03353454

A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

NCT03353454 ↗

Phase 3 Withdrawn Mirum Pharmaceuticals, Inc.
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Stopped: “The study was withdrawn due to change of ownership of the study drug maralixibat.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

EvaluationDrugModalityDoseRoute
Subject Maralixibat Small molecule 600 ug/kg Oral