Recruiting

Odevixibat

Sponsor:

Ipsen

Code:

NCT06258902

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Pregnancy Related

Study ID

NCT06258902

Start date

Sep 28, 2023

Status verified date

Aug, 2026

Completion date

May 31, 2032

Anticipated

Primary completion date

May 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Prevalence rate of major congenital malformations (MCM) at birth [ Time Frame: At birth ]

Central Contacts and Locations

Central contacts

Ipsen Clinical Study Enquiries

See e mailclinical.trials@ipsen.com

Locations

Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program

Recruiting

Wilmington, North Carolina, United States, 28401

More Information

Sponsor

Ipsen

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Rare disease
  • PFIC
  • Pregnancy
  • Lactation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ipsen on 2026-08-31.