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Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
NCT06193928 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Livmarli
Study Locations (8)
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
- Children Hospital of Pittsburgh — Pittsburgh
California
- Children's Hospital Los Angeles CHLA — Los Angeles
Colorado
- Section of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics and the Digestive Health Institute, Children's Hospital of Colorado and University of Colorado — Aurora
Georgia
- Children's Healthcare of Atlanta - Emory University School of Medicine — Atlanta
Missouri
- Children's Mercy Kansas City, Department of Gastroenterology, Section of Hepatology — Kansas City
Oregon
- Oregon Health and Science University, Division of Pediatric Gastroenterology, Department of Pediatrics — Portland
Utah
- University of Utah, Division of Pediatric Gastroenterology, Hepatology and Nutrition — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2030-09-20 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06193928
The ClinicalTrials.gov registry entry for NCT06193928 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Alagille Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Livmarli is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06193928 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Pennsylvania, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06193928 about?
NCT06193928 is a clinical study titled "Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)". 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.
What is the current status of trial NCT06193928?
This trial is currently recruiting. The enrollment target is 70 participants. The study started on 2023-09-21. Estimated completion is 2030-09-20.
What conditions does trial NCT06193928 study?
This clinical trial studies the following conditions: Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06193928?
The interventions under investigation include: Livmarli (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06193928?
This trial is sponsored by Mirum Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06193928 being conducted?
This trial has 8 study locations across California, Colorado, Georgia, Missouri, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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