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The REPLACE Registry for Cholbam® (Cholic Acid)

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 23 to 24v17
  2. Lead sponsor: Travere Therapeutics, Inc. to Mirum Pharmaceuticals, Inc.v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 23 of 23 sites
    v15
  4. Study sites: 22 to 23v14
  5. Study sites: 20 to 22v13
Show 11 earlier versionsHide 11 earlier versions
  1. Enrollment target: 110 to 55v12 Show 5 more changesShow less
    • Primary endpoints: 5 to 9
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints expanded, about 102 words
    • Study description revised
    • Study title revised
  2. Primary completion date: Jul 2030 to Jul 2038
    • Study sites: 16 to 20
    • Study completion date: Aug 2030 to Jul 2039
    • Study title expanded, about 4 words
    v11
  3. Study sites: 14 to 16v10
  4. Study sites: 12 to 14v9
  5. Study sites: 11 to 12v8
  6. Site details revised at 1 of 11 sitesv7
  7. Study sites: 9 to 11v6
  8. Study sites: 7 to 9v5
  9. Study sites: 5 to 7v4
  10. Study sites: 3 to 5
    • Start date changed from estimate of Jul 2017 to Jul 10, 2017
    v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2017 to Jul 2017
    • Primary completion date: May 2030 to Jul 2030
    • Site details revised at 3 of 3 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, observational, non-interventional patient registry study designed to document product safety and effectiveness outcomes for 10 years in patients treated with Cholbam, including those who have been using Cholbam for at least 30 days (existing users) and those who are first-time initiators of Cholbam.
Trial Details
NCT Number NCT03115086
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Bile Acid Synthesis Disorders
Related terms Peroxisomal Disorders, Zellweger Syndrome
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov