RecruitingNCT07293897

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)


Sponsor

Takeda

Enrollment

50 participants

Start Date

Jan 13, 2026

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria2

  • 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 Criteria1

  • \- None

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Interventions

DRUGMaralixibat

Maralixibat Oral Solution 10 milligrams (mg)/milliliters (mL)


Locations(1)

Takeda selected site

Tokyo, Tokyo, Japan

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NCT07293897


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