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Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

Study acronym: ELATIVE
StatusActive, Not Recruiting
PhasePhase 3
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 59 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 115 sitesv59
  2. 22 versions Re-verified since Sep 27, 2024, no change to tracked fieldsv37-v58
  3. Results first posted: Sep 5, 2024 Eligibility criteria expanded, about 20 words · Secondary endpoints: details revised at 3 of 46 entriesv36 Show 2 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 3 of 46 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoint revised Secondary endpoints: 61 to 46 · Study arms: 2 to 3v35 Show 2 more changesShow less
    • Secondary endpoints: 61 to 46
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Apr 26, 2024, no change to tracked fieldsv33-v34
Show 23 earlier versionsHide 23 earlier versions
  1. Completion date: Dec 2028 to Dec 1, 2028v32
  2. Re-verified, no change to tracked fieldsv31
  3. Eligibility criteria expanded, about 120 words Secondary endpoints: 3 to 61v30 Show 1 more changeShow less
    • Secondary endpoints: 3 to 61

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment target: estimated 150 to confirmed 161 Primary completion date changed from estimate of Sep 2023 to Jun 1, 2023 · Secondary endpoints revised (3)v29 Show 2 more changesShow less
    • Primary completion date changed from estimate of Sep 2023 to Jun 1, 2023
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  5. Lead sponsor: Genfit to Ipsenv28
  6. Re-verified, no change to tracked fieldsv27
  7. Study Status, Outcome Measuresv26
  8. Trial status: Recruiting to Active, Not Recruiting Site details revised at 115 of 115 sitesv25 Show 1 more changeShow less
    • Site details revised at 115 of 115 sites
  9. Study sites: 110 to 115v24
  10. Study sites: 103 to 110v23
  11. Study sites: 102 to 103v22
  12. Study sites: 89 to 102v21
  13. Study sites: 85 to 89v20
  14. Study sites: 76 to 85v19
  15. Study sites: 73 to 76v18
  16. Study sites: 64 to 73v17
  17. Study sites: 58 to 64v16
  18. Study sites: 53 to 58v15
  19. Study sites: 37 to 53v14
  20. Study sites: 30 to 37v13
  21. Study sites: 20 to 30v12
  22. Study sites: 13 to 20v11
  23. Study sites: 12 to 13v10
  • 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) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (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. The main aim of this study is to determine if elafibranor (the study drug) is better than placebo (a dummy treatment) at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also evaluate the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itchy skin (pruritus) and tiredness (fatigue). This study has two main parts: Part 1 will compare a daily dose of elafibranor to a daily dose of placebo and will last between a minimum of one year and a maximum of two years. Part 2, all participants will receive elafibranor for a period of up to 5 years or until the total treatment duration (part 1 and part 2) reaches 6 years, whichever occurs first.
Trial Details
NCT Number NCT04526665
Lead Sponsor Ipsen
Conditions Primary Biliary Cirrhosis
Enrollment 161 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov