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

NCT07293897 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-20

No results posted yet for this study

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).

Conditions

  • Alagille Syndrome (ALGS)
  • Progressive Familial Intrahepatic Cholestasis (PFIC)

Interventions

DRUG

Maralixibat

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

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2031-06-30
Completion
2031-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07293897 on ClinicalTrials.gov