Actively Recruiting
A Cohort Study to Investigate the Risk of Liver Disorder of Livmarli Oral Solution in Patients With Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis Using the CIRCLe Database in Japan
Led by Takeda · Updated on 2026-02-20
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a diagnosis of Alagille Syndrome (ALGS) or Progressive Familial Intrahepatic Cholestasis (PFIC) within the enrollment period
- Has a prescription for Livmarli (maralixibat) during the enrollment period
You will not qualify if you...
- None
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 years
Participants who receive maralixibat are observed using data collected from the CIRCLe Database in Japan to assess liver disorder risks.
Trial Site Locations
Total: 1 location
1
Takeda selected site
Tokyo, Tokyo, Japan
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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