Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06193928 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: LEAP
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 7 words
    • Site details revised at 5 of 8 sites
    • Study description expanded, about 2 words
  2. Primary endpoints: 5 to 4v4 Show 7 more changesShow less
    • Enrollment target: 50 to 70
    • Study completion date: Sep 20, 2028 to Sep 20, 2030
    • Interventions: Maralixibat (Drug) to Livmarli (Drug), Livmarli (Drug)
    • Study description shortened, about 14 words
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 3 words
    • Study title expanded, about 1 word
  3. Site details revised at 2 of 8 sitesv3
  4. Site details revised at 2 of 8 sitesv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT06193928
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Related terms Alagille Syndrome, Cholestasis, progressive familial intrahepatic 1, Liver Diseases
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov