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

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Ipsen
Study ID
NCT07556913
Status
Recruiting
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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Jul 29, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2039
Completion
Jan 31, 2039

Study Design

Enrollment
3 participants (estimated)

Primary Outcome Measure

Prevalence of congenital malformations at birth [ Time Frame: At birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virtual Research Coordination CenterWilmingtonNorth Carolina28401-

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Virtual Research Coordination Center· Wilmington, NC

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