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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary endpoint(s) modifiedv3
  2. Enrollment target: 100 to 230v2 Show 5 more changesShow less
    • Primary endpoints: 5 to 6
    • Study sites: 13 to 15
    • Eligibility criteria expanded, about 62 words
    • Study description shortened, about 3 words
    • Study title expanded, about 5 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In patients with Alagille syndrome (ALGS), the key objectives are to evaluate the tolerability, long-term safety (including possible liver toxicity) and long-term efficacy of Livmarli treatment. In patients with Progressive Familial Intrahepatic Cholestasis (PFIC), the key objectives are to evaluate tolerability, long-term safety (including possible liver toxicity and potential impact of chronic exposure to propylene glycol (PG)), long-term efficacy, and growth and development.
Trial Details
NCT Number NCT07290257
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Related terms Alagille Syndrome, Cholestasis, Cholestasis, progressive familial intrahepatic 1, Liver Diseases, Pruritus
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov