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NCT Number: NCT06258902

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

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.

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Key information

Conditions

Pregnancy Related Behavior Breast Feeding Disease Attributes Feeding Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program

Wilmington, North Carolina, 28401, United States

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence rate of major congenital malformations (MCM) at birth

    Time frame: 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 outcomes

  1. Prevalence rate of minor congenital malformations at birth

    Time frame: At birth

  2. Prevalence rate of molar or ectopic pregnancy

    Time frame: 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.

  3. Prevalence rate of fetal loss

    Time frame: 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).

  4. Prevalence rate of live birth

    Time frame: At birth

    The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.

  5. Prevalence rate of preterm birth

    Time frame: At birth

  6. Prevalence rate of small for gestational age (SGA)

    Time frame: At birth

    Birth weight <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.

  7. Prevalence rate of neonatal death

    Time frame: Within the first 28 days of life

  8. Prevalence rate of infant death

    Time frame: Throughout the first year of life

  9. Prevalence rate of postnatal growth deficiency

    Time frame: Throughout the first year of life

    Weight, length or head circumference in <10th percentile for sex and age using standard growth charts.

  10. Prevalence rate of infant developmental delay

    Time frame: 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)

  11. Prevalence rate of infant hospitalization due to serious illness

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ipsen Clinical Study Enquiries

CONTACT

[email protected]

See e mail

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and/or Lactation

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Feb 14, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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