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)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Japan
Takeda selected site
RECRUITING
Tokyo
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2031-06-30
Participants
Target number of participants: 50
Treatments
Alagille Syndrome (ALGS) Group
Participants with Alagille Syndrome (ALGS) who received maralixibat in accordance with package insert.
Progressive Familial Intrahepatic Cholestasis (PFIC) Group
Participants with Progressive Familial Intrahepatic Cholestasis (PFIC) who received maralixibat in accordance with package insert.
Related Therapeutic Areas
Sponsors
Leads: Takeda