Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy

Study identification

• EU PAS number:
  EUPAS1000000891
• Study ID:
  1000000891
• Official title and acronym:
  Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  European Union

  United Kingdom

  United States
• Study description:
  The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).; ; Information will be collected from participants, their healthcare providers, published studies, and safety databases. Reports of pregnancy linked to elafibranor from clinical trials, spontaneous reports, or literature will also be included, with steps taken to avoid duplicates. ; ; The study begins once the first participant is enrolled and ends after the last mother and child data are collected. It is planned to run for about 10 years, with infant follow‑up lasting up to 2 years, for a maximum total duration of 12 years and 9 months. ; ; The program is strictly observational. All medical care, visit schedules, and treatment decisions remain with healthcare providers. Only routine medical record data will be collected, and no extra tests or procedures are required. ; ; Participation is voluntary, and written informed consent will be obtained before enrollment.
• Study status:
  Planned

Research institutions and networks

Institutions

Ipsen Pharma

Study timelines

Date when funding contract was signed

Planned:30/04/2026

Study start date

Planned:30/04/2026

Date of final study report

Planned:31/01/2039

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable