Pregnancy RelatedNCT07556913
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
An observational study of Pregnancy Related, run by Ipsen at 1 site in United States.
Trial 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]). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Elafibranor
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to 31 Jan 2039
- How long will I take part?
- 33 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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])
Who may be able to join
- 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).
Who cannot join
- Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virtual Research Coordination Center
Wilmington, North Carolina, 28401
About this study
Official title: 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.
Read more
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
- Being tested
- Elafibranor
- Keywords
- Rare disease, Primary Biliary Cholangitis, Pregnancy
- Medical subject headings
- Rare Diseases, Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElafibranorDrug
The medicinal product elafibranor is prescribed in the usual manner in accordance with the terms of the marketing authorization of the participants' country.
| Study group | Role | What they receive |
|---|---|---|
| Elafibranor Cohort | Participants who are exposed to at least 1 dose of elafibranor at any time during pregnancy and/or lactation Receives: Drug: Elafibranor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of congenital malformations at birth
Measured: At birth
Secondary outcomes (22)
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At birth
Prevalence rate of premature delivery
A live birth occurring at <37 gestational weeks.
Measured: 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.
Measured: At birth
Prevalence of neonatal death
Measured: Within the first 28 days of life
Prevalence infant death
Measured: 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
Measured: 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)
Measured: 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
Measured: Throughout the two years of life
Incidence and nature of all adverse events in pregnant participants
Measured: Throughout pregnancy, an average of 9 months
Changes from baseline in Alkaline phosphatase (ALP)
Measured: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Bilirubin
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Albumin
Measured: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baselinein Bile Acids
Measured: 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)
Measured: 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
Measured: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start29 Jul 2026
- Primary completion31 Jan 2039 (estimated)
- Study completion31 Jan 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (estimated)
- Target duration
- 33 Months
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556913
- Sponsor's protocol ID
- CLIN-60190-471
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.