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A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

Study acronym: ELFIDENCE
StatusRecruiting
PhasePhase 3
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 186 → 198 locations Eligibility criteria expanded, about 23 words · Secondary endpoints: details revised at 31 of 59 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 31 of 59 entries
  2. Site details revised at 21 of 186 sitesv40
  3. Site details revised at 8 of 186 sitesv39
  4. Trial sites expanded: 183 → 186 locationsv38
  5. Trial sites expanded: 180 → 183 locations Eligibility criteria expanded, about 7 words · Secondary endpoints: 57 to 59v37 Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 57 to 59

    See this version in full on ClinicalTrials.gov ↗

  6. Trial sites expanded: 177 → 180 locationsv36
  7. Trial sites expanded: 174 → 177 locationsv35
  8. Study sites: 171 to 174v34
  9. Study sites: 169 to 171v33
  10. Study sites: 160 to 169v32
  11. Re-verified, no change to tracked fieldsv31
  12. Study sites: 158 to 160v30
  13. Study sites: 149 to 158v29
  14. Study sites: 148 to 149v28
  15. Study sites: 146 to 148v27
  16. Study sites: 131 to 146 Eligibility criteria shortened, about 7 words · Secondary endpoints: details revised at 1 of 57 entriesv26 Show 2 more changesShow less
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: details revised at 1 of 57 entries

    See this version in full on ClinicalTrials.gov ↗

  17. Re-verified, no change to tracked fieldsv25
  18. Study sites: 130 to 131v24
  19. Site details revised at 7 of 130 sitesv23
  20. Site details revised at 1 of 130 sitesv22
  21. Site details revised at 5 of 130 sitesv21
  22. Study sites: 126 to 130v20
  23. Study sites: 110 to 126v19
  24. Study sites: 89 to 110 Primary completion date: May 2029 to May 31, 2029 · Completion date: May 2030 to May 31, 2029v18 Show 2 more changesShow less
    • Primary completion date: May 2029 to May 31, 2029
    • Completion date: May 2030 to May 31, 2029
  25. Completion date: May 2029 to May 2030 Secondary endpoints: details revised at 6 of 57 entriesv17 Show 1 more changeShow less
    • Secondary endpoints: details revised at 6 of 57 entries
  26. Re-verified, no change to tracked fieldsv16
  27. Enrollment target: 450 to 276 Primary and study completion dates: Oct 18, 2030 to May 2029 · Eligibility criteria shortened, about 128 words · Secondary endpoints: 55 to 57v15 Show 3 more changesShow less
    • Primary and study completion dates: Oct 18, 2030 to May 2029
    • Eligibility criteria shortened, about 128 words
    • Secondary endpoints: 55 to 57

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 39 to 89v14
  29. Re-verified, no change to tracked fieldsv13
  30. Study sites: 15 to 39v12
  31. 2 versions Re-verified since Mar 27, 2024, no change to tracked fieldsv10-v11
  32. Study sites: 9 to 15v9
  33. Re-verified, no change to tracked fieldsv8
  34. Study sites: 5 to 9v7
  35. Re-verified, no change to tracked fieldsv6
  36. Eligibility criteria expanded, about 23 words Secondary endpoints revised (55)v5 Show 1 more changeShow less
    • Secondary endpoints revised (55)

    See this version in full on ClinicalTrials.gov ↗

  37. Study sites: 4 to 5 Start date changed from estimate of Sep 2023 to Aug 31, 2023v4 Show 1 more changeShow less
    • Start date changed from estimate of Sep 2023 to Aug 31, 2023
  38. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date: Aug 31, 2023 to Sep 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date: Aug 31, 2023 to Sep 2023
  39. Secondary endpoints revised (55)v2 See this version in full on ClinicalTrials.gov ↗
  40. 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.
Ipsen
46 trials monitored
See 4 trials at risk
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
Trial Details
NCT Number NCT06016842
Lead Sponsor Ipsen
Conditions Primary Biliary Cholangitis (PBC)
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov