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

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

Record History

The 50 most recent of 54 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoingv54 Show 4 more changesShow less
    • Enrollment increased: 260 → 333 participants
    • Primary completion moved earlier from Apr 2027 to Jan 2027
    • Study completion pushed from Jul 2027 to Dec 2028
    • Site details revised at 130 of 130 sites
  2. Site details revised at 110 of 130 sitesv53
  3. Site details revised at 113 of 130 sitesv52
  4. Trial sites expanded: 127 → 130 locations
    • Trial sites expanded: 123 → 127 locations
    v51
  5. Study sites: 123 to 127v50
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 121 to 123v49
  2. Study sites: 115 to 121v48
  3. Study sites: 113 to 115v47
  4. Study sites: 105 to 113v46
  5. Study sites: 103 to 105v45
  6. Study sites: 101 to 103v44
  7. Primary completion date: Dec 2025 to Apr 2027v43 Show 4 more changesShow less
    • Enrollment target: 180 to 260
    • Study sites: 102 to 101
    • Study completion date: Dec 2025 to Jul 2027
    • Eligibility criteria expanded, about 2 words
  8. Study sites: 96 to 102v42
  9. Study sites: 92 to 96v41
  10. Study sites: 91 to 92v40
  11. Site details revised at 1 of 91 sitesv39
  12. Study sites: 87 to 91v38
  13. Study sites: 85 to 87
    • Study arms: 2 to 5
    v37
  14. Study sites: 84 to 85v36
  15. Study sites: 83 to 84v35
  16. Study sites: 78 to 83v34
  17. Study sites: 77 to 78v33
  18. Study sites: 74 to 77v32
  19. Study sites revised (74)v31
  20. Study sites: 71 to 74v30
  21. Study sites: 69 to 71v29
  22. Eligibility criteria expanded, about 11 words
    • Study arms: 3 to 2
    v28
  23. Study sites: 67 to 69v27
  24. Study sites: 66 to 67v26
  25. Study sites: 64 to 66v25
  26. Study sites: 63 to 64v24
  27. Study sites: 61 to 63v23
  28. Study sites: 60 to 61v22
  29. Site details revised at 2 of 60 sitesv21
  30. Study sites: 59 to 60v20
  31. Enrollment target: 260 to 180
    • Primary completion date: Dec 2023 to Dec 2025
    • Study sites: 58 to 59
    • Secondary endpoints: 11 to 8
    v19
  32. Study sites: 57 to 58v18
  33. Study sites: 52 to 57v17
  34. Study sites: 50 to 52v16
  35. Study sites: 48 to 50v15
  36. Study sites: 42 to 48v14
  37. Study sites: 38 to 42v13
  38. Study sites: 37 to 38v12
  39. Study sites: 31 to 37v11
  40. Study sites: 27 to 31v10
  41. Study sites: 26 to 27v9
  42. Study sites: 20 to 26v8
  43. Study sites: 17 to 20v7
  44. Re-verified, no change to tracked fieldsv6
  45. Study sites: 14 to 17v5
  • 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 Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
Trial Details
NCT Number NCT05050136
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Primary Biliary Cholangitis, PBC
Related terms Cholangitis, Digestive System Diseases, Liver Cirrhosis, Biliary, Pruritus
Enrollment 333 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov