NCT07290257

Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome in the European Union (LEAP-EU)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

Summary

The key objectives of this low-intervention clinical study are to evaluate tolerability, long-term safety and long-term efficacy for patients with Alagille syndrome (ALGS) who are prescribed Livmarli.

Detailed description

This is a multicenter, open-label, low-intervention clinical study in participants diagnosed with Alagille syndrome (ALGS) who are treated with Livmarli for cholestatic pruritus. Participants will be treated according to standard of care for the duration of the study and Schedule of Assessments.

Conditions

• Alagille Syndrome

Interventions

Type	Name	Description
DRUG	Livmarli Oral Product	Participants will be treated according to standard of care for the duration of the study and Schedule of Assessments.

Timeline

• Start date: 2025-09-25
• Primary completion: 2030-09-22
• Completion: 2030-12-22
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

13 sites across 6 countries: Belgium, France, Germany, Italy, Netherlands, Spain