Clinical Trial

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

Recruiting
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-17.
Status change: Not Yet Recruiting → Recruiting 2026-02-18
Trial Details
NCT Number NCT07293897
Lead Sponsor Takeda
Conditions Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
Enrollment 50 participants
Start Date 2026-01-13
Primary Completion 2031-06-30 (estimated)
Study Completion 2031-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-20