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

Progressive Familial Intrahepatic Cholestasis (PFIC) Clinical Trial

Official title:
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Status Withdrawn

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cholestasis
Cholestasis, Intrahepatic
Progressive Familial Intrahepatic Cholestasis (PFIC)

Clinical Trial Details

NCT number	NCT03353454
Study type	Interventional
Source	Mirum Pharmaceuticals, Inc.
Contact
Status	Withdrawn
Phase	Phase 3
Start date	October 25, 2018
Completion date	June 15, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02057718` - Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis	Phase 2
Completed	`NCT03905330` - A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)	Phase 3
Active, not recruiting	`NCT04185363` - An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)	Phase 3
Active, not recruiting	`NCT05543187` - A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)	Phase 3