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Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and/or Lactation
Who can join
All ages · Women
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Refusal to provide informed consent, if required
About the study
The participants of this study will be of any age who are exposed 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.
This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance.
Study start date is either start of data collection or first patient enrolled whatever occurs earlier.
The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected.
No additional laboratory tests or HCP assessments will be required as part of this surveillance program.
Sponsor: Ipsen · Participants: 20 · Started: Sep 28, 2023
Contact the study team
- Ipsen Clinical Study Enquiries · Phone: See e mail
Official record on ClinicalTrials.gov — NCT06258902
Locations in the U.S.
| North Carolina | Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program, Wilmington |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.