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A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Study acronym: VISTAS
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Jun 2026 to Feb 20, 2026
    • Study completion pushed from Apr 2027 to Mar 2028
    v58
  2. Study sites revised (103)v57
  3. 2 versions Re-verified since Nov 18, 2025, no change to tracked fieldsv55-v56
  4. Primary completion date: Sep 2025 to Jun 2026v54 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 182
    • Study completion date: Dec 2025 to Apr 2027
    • Site details revised at 103 of 103 sites
  5. Site details revised at 1 of 103 sitesv53
Show 44 earlier versionsHide 44 earlier versions
  1. Site contacts updated at 1 of 103 sitesv52
  2. Site details revised at 6 of 103 sitesv51
  3. Site contacts updated at 2 of 103 sitesv50
  4. Site contacts updated at 6 of 103 sitesv49
  5. Study sites: 102 to 103v48
  6. Study sites revised (102)v47
  7. Site contacts updated at 5 of 102 sitesv46
  8. Study sites: 100 to 102v45
  9. Study sites: 96 to 100v44
  10. Study sites: 90 to 96v43
  11. Site contacts updated at 1 of 90 sitesv42
  12. Study sites: 84 to 90v41
  13. Site contacts updated at 5 of 84 sitesv40
  14. Study sites: 75 to 84v39
  15. Study sites: 72 to 75
    • Study arms: 3 to 5
    v38
  16. Site details revised at 1 of 72 sitesv37
  17. Study sites: 71 to 72v36
  18. Site contacts updated at 1 of 71 sitesv35
  19. Study sites: 67 to 71v34
  20. Study sites: 63 to 67
    • Eligibility criteria expanded, about 7 words
    v33
  21. Site contacts updated at 4 of 63 sitesv32
  22. Study sites: 62 to 63v31
  23. Site contacts updated at 7 of 62 sitesv30
  24. Study sites: 61 to 62v29
  25. Secondary endpoints: 10 to 8v28
  26. Primary completion date: Sep 2024 to Sep 2025
    • Study sites: 60 to 61
    • Eligibility criteria expanded, about 2 words
    v27
  27. Study sites: 55 to 60v26
  28. Site contacts updated at 2 of 55 sitesv25
  29. Site details revised at 4 of 55 sitesv24
  30. Study sites: 51 to 55v23
  31. Site contacts updated at 1 of 51 sitesv22
  32. Site contacts updated at 1 of 51 sitesv21
  33. Study sites: 44 to 51v20
  34. Study sites: 45 to 44v19
  35. Study sites: 46 to 45v18
  36. Study sites: 45 to 46
    • Eligibility criteria expanded, about 7 words
    v17
  37. Study sites: 44 to 45v16
  38. Study sites: 37 to 44v15
  39. Study sites: 33 to 37v14
  40. Study sites: 26 to 33v13
  41. Site details revised at 14 of 26 sitesv12
  42. Primary completion date: Dec 2022 to Sep 2024
    • Site details revised at 4 of 26 sites
    v11
  43. Secondary endpoints revised (10)
    • Site details revised at 2 of 26 sites
    v10
  44. Site details revised at 6 of 26 sites
    • Study title expanded, about 1 word
    v9
  • 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 clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
Trial Details
NCT Number NCT04663308
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Primary Sclerosing Cholangitis
Related terms Cholangitis, Sclerosing, Cholestasis, Pruritus
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov