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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTakeda

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Maralixibat

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators