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

Recruiting now

Conditions studied: Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)

In brief

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).

Key facts

Study ID

NCT07293897

Run by

Takeda

People needed

50

Starts

2026-01-13

Expected to finish

2031-06-30

Last updated by the study team

2026-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• None

Where it is running

• Takeda selected site — Tokyo, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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