A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
NCT ID: NCT07293897
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2026-01-09
2031-06-30
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Alagille Syndrome (ALGS) Group
Participants with Alagille Syndrome (ALGS) who received maralixibat in accordance with package insert.
Maralixibat
Maralixibat Oral Solution 10 milligrams (mg)/milliliters (mL)
Progressive Familial Intrahepatic Cholestasis (PFIC) Group
Participants with Progressive Familial Intrahepatic Cholestasis (PFIC) who received maralixibat in accordance with package insert.
Maralixibat
Maralixibat Oral Solution 10 milligrams (mg)/milliliters (mL)
Interventions
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Maralixibat
Maralixibat Oral Solution 10 milligrams (mg)/milliliters (mL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* There is a prescription for Livmarli during the enrollment period (Index date: the date of the first prescription within the enrollment period).
Exclusion Criteria
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Central Contacts
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Other Identifiers
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TAK-625-4002
Identifier Type: -
Identifier Source: org_study_id