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

NCT07556913 | Not Yet Recruiting

• 1 other identifier: CLIN-60190-471
• Study Type: observational
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy Related

Keywords

Rare disease; Primary Biliary Cholangitis; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Prevalence of congenital malformations at birth

  At birth

Secondary Outcomes (22)

• Prevalence of major congenital malformations at birth

  At birth

• Prevalence of minor congenital malformations at birth

  At birth

• Prevalence of molar/ectopic pregnancy

  Throughout pregnancy, an average of 9 months

• Prevalence of fetal loss

  Throughout pregnancy, an average of 9 months

• Prevalence of live birth

  At birth

Eligibility Criteria

• Gender Eligibility Details: Child-bearing potential women: individuals of any age who are exposed to at least 1 dose of elafibranor at any time during pregnancy and/or lactation.
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants of this study will be of any age who are exposed to at least one dose of elafibranor at any time during pregnancy, or since 3 weeks prior to the conception (based on estimated last menstrual period \[LMP\])

You may qualify if:

• Maternal exposure to at least one dose of elafibranor, either: Within three weeks prior to conception (based on the estimated date of LMP) or At any time during pregnancy (from the estimated date of conception through pregnancy outcome).
• Informed consent or IRB/IEC-approved waiver of informed consent (not applicable if reported by Ipsen PV according to usual pharmacovigilance practices).

You may not qualify if:

• Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Sponsors & Collaborators

• Ipsen: lead

MeSH Terms

Conditions

Rare Diseases; Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Central Study Contacts

Ipsen Clinical Study Enquiries

CONTACT

See e-mail; clinical.trials@ipsen.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 33 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): January 31, 2039
• Study Completion (Estimated): January 31, 2039
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).