A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC) — MARCH-PFIC

Progressive Familial Intrahepatic Cholestasis (PFIC) Clinical Trial

Official title:
MRX-502: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) - MARCH-PFIC

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).

Clinical Trial Description

This study was conducted at multiple sites in North America, Europe, Asia and South America. ;

Study Design

Related Conditions & MeSH terms

Cholestasis
Cholestasis, Intrahepatic
Progressive Familial Intrahepatic Cholestasis (PFIC)

Clinical Trial Details

NCT number	NCT03905330
Study type	Interventional
Source	Mirum Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	July 9, 2019
Completion date	September 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT03353454` - A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)	Phase 3
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
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