Loading clinical trials...

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

RECRUITING

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)

NCT07293897•Takeda

View on ClinicalTrials.gov

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).

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a diagnosis of ALGS or PFIC within the enrollment period.
•There is a prescription for Livmarli during the enrollment period (Index date: the date of the first prescription within the enrollment period).

Exclusion Criteria

•\- None

Locations (1)

Takeda selected site

Tokyo, Tokyo, Japan

Key Dates

Start Date

January 13, 2026

Primary Completion Date

June 30, 2031

Completion Date

June 30, 2031

Last Updated

February 20, 2026

Enrollment

ESTIMATED participants

Conditions

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

Interventions

Maralixibat

DRUG

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

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

NCT03905330

Progressive Familial Intrahepatic Cholestasis (PFIC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions