NCT07293897

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)

A Cohort Study to Investigate the Risk of Liver Disorder of Livmarli Oral Solution in Patients With Japan Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) Registered in the Comprehensive and Informative Registry System for Childhood Liver Disease (CIRCLe)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). The main aim of the study is to evaluate the risk of liver disorder during the use of maralixibat in Japanese patients with ALGS or PFIC. This database study will conduct in use of medical database called Comprehensive and Informative Registry system for Childhood Liver Disease (CIRCLe).

Conditions

• Alagille Syndrome (ALGS)
• Progressive Familial Intrahepatic Cholestasis (PFIC)

Interventions

Type	Name	Description
DRUG	Maralixibat	Maralixibat Oral Solution 10 milligrams (mg)/milliliters (mL)

Timeline

• Start date: 2026-01-13
• Primary completion: 2031-06-30
• Completion: 2031-06-30
• First posted: 2025-12-19
• Last updated: 2026-02-20

Locations

1 site across 1 country: Japan