deltatrials
Recruiting OBSERVATIONAL NCT06447168

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

Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.

Sponsor: Ipsen

Updated 17 times since 2024 Last updated: Apr 29, 2026 Started: Oct 14, 2024 Primary completion: Jul 15, 2032 Completion: Jul 15, 2032
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Primary Biliary Cholangitis and is currently actively recruiting participants. Ipsen leads this study, which shows 17 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshotRecruiting~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Jan 2026 · 2 months · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – ~May 2026 · 2 months · monthly snapshotRecruitingMay 4, 2026 – present · 4 months · daily APIRecruiting

Change History

17 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

  2. Mar 2026 — May 2026 [monthly]

    Recruiting

  3. Feb 2026 — Mar 2026 [monthly]

    Recruiting

  4. Jan 2026 — Feb 2026 [monthly]

    Recruiting

  5. Nov 2025 — Jan 2026 [monthly]

    Recruiting

Show 12 earlier versions
  1. Oct 2025 — Nov 2025 [monthly]

    Recruiting

  2. Sep 2025 — Oct 2025 [monthly]

    Recruiting

  3. Jun 2025 — Sep 2025 [monthly]

    Recruiting

  4. May 2025 — Jun 2025 [monthly]

    Recruiting

  5. Mar 2025 — May 2025 [monthly]

    Recruiting

  6. Feb 2025 — Mar 2025 [monthly]

    Recruiting

  7. Jan 2025 — Feb 2025 [monthly]

    Recruiting

  8. Dec 2024 — Jan 2025 [monthly]

    Recruiting

  9. Nov 2024 — Dec 2024 [monthly]

    Recruiting

  10. Oct 2024 — Nov 2024 [monthly]

    Recruiting

    Status: Not Yet RecruitingRecruiting

  11. Sep 2024 — Oct 2024 [monthly]

    Not Yet Recruiting

  12. Jul 2024 — Sep 2024 [monthly]

    Not Yet Recruiting

    First recorded

Eligibility Summary

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).

Contact Information

Sponsor contact:
  • Ipsen
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .