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

RECRUITINGSponsored by Takeda
Actively Recruiting
SponsorTakeda
Started2026-01-13
Est. completion2031-06-30
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07293897

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

Healthy volunteers accepted
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

Conditions4

Alagille Syndrome (ALGS)Heart DiseaseLiver DiseaseProgressive Familial Intrahepatic Cholestasis (PFIC)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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