Actively Recruiting
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Led by Ipsen · Updated on 2026-04-30
20
Participants Needed
1
Research Sites
452 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 pharmacovigilance according to usual pharmacovigilance practices)
You will not qualify if you...
- Refusal to provide informed consent, if required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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