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

Pregnancy Related Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258902
• Other study ID #: A4250-017
• Status: Recruiting
• Start date: September 28, 2023
• Est. completion date: September 2, 2032

Study information

• Verified date: April 2024
• Source: Ipsen
• Contact: Ipsen Clinical Study Enquiries
• Phone: See e mail
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2, 2032
• Est. primary completion date: September 2, 2031
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Locations

Country	Name	City	State
United States	Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence rate of minor congenital malformations at birth		At birth
Secondary	Prevalence rate of molar or ectopic pregnancy	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.	Throughout pregnancy, an average of 9 months
Secondary	Prevalence rate of fetal loss	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).	Throughout pregnancy, an average of 9 months
Secondary	Prevalence rate of live birth	The birth of a living fetus at = 20 gestational weeks or, if gestational age is unknown, weighing = 350g.	At birth
Secondary	Prevalence rate of preterm birth		At birth
Secondary	Prevalence rate of small for gestational age (SGA)	Birth weight <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.	At birth
Secondary	Prevalence rate of neonatal death		Within the first 28 days of life
Secondary	Prevalence rate of infant death		Throughout the first year of life
Secondary	Prevalence rate of postnatal growth deficiency	Weight, length or head circumference in <10th percentile for sex and age using standard growth charts.	Throughout the first year of life
Secondary	Prevalence rate of infant developmental delay	Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC)	Throughout the first year of life
Secondary	Prevalence rate of infant hospitalization due to serious illness	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)	Throughout the first year of life