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Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)

Recruitingn/aAges any - anyAllMirum Pharmaceuticals, Inc.
NCT06193928 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC) treated with Livmarli.

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📋 Eligibility rules (as published)
Inclusion Criteria: * A clinically and/or genetically confirmed ALGS diagnosis or PFIC diagnosis * Participant prescribed Livmarli Exclusion Criteria: * Refusal to provide informed consent/assent (if required by the local IRB) * Previously or currently on Livmarli through participation in a clinical study or expanded access program * Participants who have previously received an SBD or LT * Any condition or abnormalities that, in the opinion of the investigator, may interfere with the participant participating in or completing the study * Participants who have received an investigational drug within 30 days of the first dose of Livmarli
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What it tests

  • Livmarli
  • Livmarli
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Where

8 sites
Children's Hospital Los Angeles CHLA
Los Angeles, United States
Section of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics and the Digestive Health Institute, Children's Hospital of Colorado and University of Colorado
Aurora, United States
Children's Healthcare of Atlanta - Emory University School of Medicine
Atlanta, United States
Children's Mercy Kansas City, Department of Gastroenterology, Section of Hepatology
Kansas City, United States
Oregon Health and Science University, Division of Pediatric Gastroenterology, Department of Pediatrics
Portland, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Children Hospital of Pittsburgh
Pittsburgh, United States
University of Utah, Division of Pediatric Gastroenterology, Hepatology and Nutrition
Salt Lake City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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