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

NCT06258902 | Recruiting

• 1 other identifier: A4250-017
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Rare disease; PFIC; Pregnancy; Lactation

Outcome Measures

Primary Outcomes (1)

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

  At birth

Secondary Outcomes (11)

• Prevalence rate of minor congenital malformations at birth

  At birth

• Prevalence rate of molar or ectopic pregnancy

  Throughout pregnancy, an average of 9 months

• Prevalence rate of fetal loss

  Throughout pregnancy, an average of 9 months

• Prevalence rate of live birth

  At birth

• Prevalence rate of preterm birth

  At birth

Eligibility Criteria

• Gender Eligibility Details: Child-bearing potential women: individuals of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy and/or lactation.
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The main population will be individuals 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).

You may qualify if:

• 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)

You may not qualify if:

• Refusal to provide informed consent, if required

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program

Wilmington, North Carolina, 28401, United States

RECRUITING

MeSH Terms

Conditions

Rare Diseases; Breast Feeding

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Central Study Contacts

Ipsen Clinical Study Enquiries

CONTACT

See e mail; clinical.trials@ipsen.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 14, 2024
• Study Start: September 28, 2023
• Primary Completion (Estimated): May 31, 2032
• Study Completion (Estimated): May 31, 2032
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

US (1)