NCT06193928 Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
| NCT ID | NCT06193928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mirum Pharmaceuticals, Inc. |
| Condition | Alagille Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-09-21 |
| Primary Completion | 2028-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2023-09-21 with a primary completion date of 2028-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06193928 clinical trial?
This trial is open to participants of all sexes, studying Alagille Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06193928 currently recruiting?
Yes, NCT06193928 is actively recruiting participants. Contact the research team at Clinical Trials <clinicaltrials@mirumpharma.com>; for enrollment information.
Where is the NCT06193928 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, Atlanta, United States, Kansas City, United States and 4 additional locations.
Who is sponsoring the NCT06193928 clinical trial?
NCT06193928 is sponsored by Mirum Pharmaceuticals, Inc.. The trial plans to enroll 70 participants.