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Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 24 to 23
    • Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv16
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 35 → 24 locations
    • Eligibility criteria expanded, about 583 words
    v15
  4. Site details revised at 4 of 35 sitesv14
  5. Site details revised at 1 of 35 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Site details revised at 6 of 35 sitesv12
  2. Study sites: 34 to 35v11
  3. Site contacts updated at 2 of 34 sitesv10
  4. Study sites: 32 to 34
    • Eligibility criteria expanded, about 18 words
    v9
  5. Site details revised at 11 of 32 sitesv8
  6. Site details revised at 9 of 32 sitesv7
  7. Site details revised at 2 of 32 sitesv6
  8. Study sites: 27 to 32
    • Primary completion date: Sep 2026 to Oct 2026
    v5
  9. Study sites: 25 to 27v4
  10. Start date changed from estimate of Oct 2024 to Oct 14, 2024
    • Site details revised at 4 of 25 sites
    v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 22 to 25
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.
Trial Details
NCT Number NCT06553768
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Related terms Biliary Atresia, Cholangitis, Sclerosing, Pruritus
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov