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A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

Study acronym: ELFINITY
StatusActive, Not Recruiting
PhaseNot specified
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Study sites: 74 to 72 · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 12 of 22 entries Show 3 more changesShow less
    • Study sites: 74 to 72
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 12 of 22 entries
  2. Site details revised at 1 of 74 sitesv26
  3. Trial sites expanded: 68 → 74 locationsv25
  4. Site details revised at 3 of 68 sitesv24
  5. Trial sites expanded: 65 → 68 locationsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Site details revised at 4 of 65 sitesv22
  2. Study sites: 63 to 65v21
  3. Study sites: 58 to 63v20
  4. Study sites: 57 to 58v19
  5. Study sites: 56 to 57v18
  6. Study sites: 50 to 56v17
  7. Study sites: 46 to 50v16
  8. Study sites: 44 to 46v15
  9. Re-verified, no change to tracked fieldsv14
  10. Study sites: 42 to 44v13
  11. Eligibility criteria shortened, about 25 words Secondary endpoints: 21 to 22v12 Show 1 more changeShow less
    • Secondary endpoints: 21 to 22

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 36 to 42v11
  13. Study sites: 33 to 36v10
  14. Study sites: 32 to 33v9
  15. Study sites: 23 to 32v8
  16. Study sites: 19 to 23v7
  17. Primary and study completion dates: Jul 15, 2029 to Jul 15, 2032 Study sites: 2 to 19v6 Show 1 more changeShow less
    • Study sites: 2 to 19
  18. Re-verified, no change to tracked fieldsv5
  19. Start date changed from estimate of Nov 30, 2024 to Oct 14, 2024 Site details revised at 1 of 2 sitesv4 Show 1 more changeShow less
    • Site details revised at 1 of 2 sites
  20. Start date: Oct 31, 2024 to Nov 30, 2024v3
  21. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 15, 2024 to Oct 31, 2024 · Study sites: 0 to 2v2 Show 2 more changesShow less
    • Start date: Jul 15, 2024 to Oct 31, 2024
    • Study sites: 0 to 2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Ipsen
46 trials monitored
See 4 trials at risk
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).
Trial Details
NCT Number NCT06447168
Lead Sponsor Ipsen
Conditions Primary Biliary Cholangitis
Enrollment 424 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov