Study of Maralixibat Livmarli Use and Liver Disorder Risk in Japanese Patients with Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis Using the CIRCLe Database

What this Trial Is About

Researchers are observing the use of maralixibat TAK-625 in Japanese patients diagnosed with Alagille Syndrome ALGS or Progressive Familial Intrahepatic Cholestasis PFIC. The main goal is to evaluate the risk of liver disorders during treatment with maralixibat. This study uses data from the Comprehensive and Informative Registry system for Childhood Liver Disease CIRCLe to gather information on these patients. The study groups include participants with ALGS and participants with PFIC, all of whom have received maralixibat oral solution according to the official prescribing information. The research involves analyzing existing medical records and prescriptions within the CIRCLe database to assess liver disorder risks over a period of up to six years. Participants liver health is monitored through evaluations of liver disorder occurrence and the timing of onset using defined outcome measures for side effects and adverse events. Researchers will review the percentage of patients experiencing liver disorders and how soon these occur after starting maralixibat treatment, using data collected over several years. The study does not involve direct intervention but relies on existing registry and medical data.

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