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

Recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT06258902
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-28
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2031-09-02
• Study Completion: 2032-09-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence rate of major congenital malformations (MCM) at birth	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence rate of minor congenital malformations at birth	At birth
Prevalence rate of infant developmental delay	Throughout the first year of life	Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC)
Prevalence rate of preterm birth	At birth
Prevalence rate of molar or ectopic pregnancy	Throughout pregnancy, an average of 9 months	Molar pregnancy is defined as an abnormal pregnancy that happens when a sperm fertilizes an egg that does not contain any genetic material. Ectopic pregnancy is defined as a pregnancy that occurs outside of the uterine cavity, usually in one of the fallopian tubes.
Prevalence rate of fetal loss	Throughout pregnancy, an average of 9 months	A fetal loss that occurs for any reason at any time during pregnancy. This includes spontaneous abortion (SAB), stillbirth, elective or therapeutic abortion, fetal loss (type not specified).
Prevalence rate of neonatal death	Within the first 28 days of life
Prevalence rate of infant death	Throughout the first year of life
Prevalence rate of live birth	At birth	The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.
Prevalence rate of postnatal growth deficiency	Throughout the first year of life	Weight, length or head circumference in \<10th percentile for sex and age using standard growth charts.
Prevalence rate of infant hospitalization due to serious illness	Throughout the first year of life	Infant hospital visit due to a serious (i.e. results in significant disability, incapacity, or death; is life-threatening; requires inpatient or prolonged hospitalization; or is considered medically important)
Prevalence rate of small for gestational age (SGA)	At birth	Birth weight \<10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.

Trial Locations

Locations (1)

Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program; 🇺🇸 Wilmington, North Carolina, United States