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Odevixibat Safety During Pregnancy and Breastfeeding

This observational study is looking at the safety of odevixibat when taken during pregnancy or while breastfeeding. Researchers want to understand if taking odevixibat at any point from just before conception through pregnancy, or during breastfeeding (up to 12 months of the baby's age), is linked to major birth defects. You can join if you are a woman who has been exposed to odevixibat during these times. The study will collect information from you, your healthcare providers, and drug safety reports. This is an observational study, meaning your doctors will decide your care, not the study.

Study design
This is an observational study with a planned enrollment of 20 women. It is not a randomized trial, and the phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, major congenital malformations, is measured at birth.

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NCT06258902

Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

Recruiting
Not specifiedAll AgesObservational
Ipsen
~20 participants
Updated 2026-08-03 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence rate of major congenital malformations (MCM) at birth
Measured over At birth

Conditions

Pregnancy Related

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PregnancyProgressive Familial Intrahepatic CholestasisWeaning

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Ipsen Medical Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Clinical Study Enquiries
[email protected]
See e mail
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Exposure to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first).
Informed consent or IRB-/EC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices)

Exclusion

Refusal to provide informed consent, if required

What this trial measures

  • Prevalence rate of major congenital malformations (MCM) at birthAt 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.