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

Elafibranor Pregnancy Surveillance Program: A Post Marketing, Long Term, Multi-Center, Noninterventional, and Descriptive Study to Characterize Pregnancy and Maternal Complications and to Describe Effects on the Developing Fetus, Neonate and Infant Among Individuals Exposed to Elafibranor During Pregnancy

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 Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related

• Study Type: Observational
• Enrollment (Estimated): 3

Contacts and Locations

• Study Contact: Name: Ipsen Clinical Study Enquiries; Phone Number: See e-mail; Email: clinical.trials@ipsen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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])

Description

Inclusion Criteria:

• 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).
• Participants who were previously enrolled in this program during a past pregnancy and who meet inclusion criteria #1 for the subsequent pregnancy are eligible to enroll again.
• Informed consent or IRB/IEC-approved waiver of informed consent (not applicable if reported by Ipsen PV according to usual pharmacovigilance practices).

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of congenital malformations at birth	At birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of major congenital malformations at birth	An abnormality of body structure or function that is present at birth; is of prenatal origin (i.e. birth defect); has significant medical, social, or cosmetic consequences for the affected individual; and typically requires medical intervention	At birth
Prevalence of minor congenital malformations at birth	An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e. birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual	At birth
Prevalence of molar/ectopic pregnancy	Molar pregnancy is defined as an abnormal pregnancy that happens when a sperm fertilizes an egg that does not contain any genetic material. Ectopic pregnancy is defined as a pregnancy that occurs outside of the uterine cavity, usually in one of the fallopian tubes.	Throughout pregnancy, an average of 9 months
Prevalence of fetal loss	A fetal loss that occurs for any reason at any time during pregnancy. This includes spontaneous abortion (SAB), stillbirth, elective or therapeutic abortion, fetal loss (type not specified).	Throughout pregnancy, an average of 9 months
Prevalence of live birth	The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.	At birth
Prevalence rate of premature delivery	A live birth occurring at <37 gestational weeks.	At birth
Prevalence of infants born small for gestational age (SGA) at birth	Birth weight <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.	At birth
Prevalence of neonatal death		Within the first 28 days of life
Prevalence infant death		Throughout the first year of life
Prevalence of postnatal growth deficiency	Weight, length, or head circumference in <10th percentile for sex and age using standard growth charts	Throughout the two years of life
Prevalence of infant developmental delay	Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC)	Throughout the two years of life
Prevalence of infant healthcare requirements and interventions not considered standard	including but not limited to: Infant hospitalization due to serious illness; Emergency department visits; Specialist or other healthcare professional consultations; Developmental assessments and interventions; Therapeutic services; Educational support and adaptations	Throughout the two years of life
Incidence and nature of all adverse events in pregnant participants		Throughout pregnancy, an average of 9 months
Changes from baseline in Alkaline phosphatase (ALP)		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Bilirubin		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Alanine aminotransferase (ALT)		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Aspartate aminotransferase (AST)		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Gamma-glutamyl transferase (GGT)		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Albumin		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baselinein Bile Acids		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Creatine phosphokinase (CPK)		From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Lipid Profile	Lipid profile includes total cholesterol, low density lipoproteins (LDL-C), high density lipoprotein (HDL-C), very low density lipoprotein and triglycerides	From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): January 31, 2039
• Study Completion (Estimated): January 31, 2039

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Rare disease; Primary Biliary Cholangitis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Digestive System Diseases; Biliary Tract Diseases; Liver Diseases; Bile Duct Diseases; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Pathological Conditions, Signs and Symptoms; Rare Diseases; Liver Cirrhosis, Biliary
• Other Study ID Numbers: CLIN-60190-471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
• IPD Sharing 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.
• IPD Sharing 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/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No