Clinical trial NCT06258902: Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Keywords: Rare disease
PFIC
Pregnancy
Lactation
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence rate of major congenital malformations (MCM) at birth
timeFrame: At birth
Secondary outcomes:
measure: Prevalence rate of minor congenital malformations at birth
timeFrame: At birth
measure: Prevalence rate of molar or ectopic pregnancy
timeFrame: Throughout pregnancy, an average of 9 months
measure: Prevalence rate of fetal loss
timeFrame: Throughout pregnancy, an average of 9 months
measure: Prevalence rate of live birth
timeFrame: At birth
measure: Prevalence rate of preterm birth
timeFrame: At birth
measure: Prevalence rate of small for gestational age (SGA)
timeFrame: At birth
measure: Prevalence rate of neonatal death
timeFrame: Within the first 28 days of life
measure: Prevalence rate of infant death
timeFrame: Throughout the first year of life
measure: Prevalence rate of postnatal growth deficiency
timeFrame: Throughout the first year of life
measure: Prevalence rate of infant developmental delay
timeFrame: Throughout the first year of life
measure: Prevalence rate of infant hospitalization due to serious illness
timeFrame: Throughout the first year of life
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program
state: North Carolina
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: