An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Progressive Familial Intrahepatic Cholestasis (PFIC) Clinical Trial

Official title:
An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

Status Active, not recruiting

Clinical Trial Summary

The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.

Clinical Trial Description

The study will be 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	NCT04185363
Study type	Interventional
Source	Mirum Pharmaceuticals, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	January 8, 2020
Completion date	September 2024

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Withdrawn	`NCT03353454` - A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)	Phase 3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
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	`NCT05543187` - A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)	Phase 3