Monitoring the safety of odevixibat during pregnancy and breastfeeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational program aims to evaluate the safety of odevixibat in individuals who are pregnant or lactating. Participants of any age who have received at least one dose of odevixibat during pregnancy or lactation will be included. Data will be collected from various sources, including participants and healthcare providers, without requiring additional tests or assessments beyond routine medical care. The program focuses on gathering information on the effects of odevixibat on both mothers and infants.

Why it matters

Who can join: the full rules

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

Where it's running

• Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Ipsen Clinical Study Enquiries
• Email: clinical.trials@ipsen.com
• Phone: See e mail

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.