Pregnancy RelatedNCT06258902
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
An observational study of Pregnancy Related, run by Ipsen at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 31 May 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Refusal to provide informed consent, if required
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program
Wilmington, North Carolina, 28401
About this study
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
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.
Read more
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
- Medical subject headings
- Rare Diseases, Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At birth
Secondary outcomes (11)
Prevalence rate of minor congenital malformations at birth
Measured: At birth
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.
Measured: Throughout pregnancy, an average of 9 months
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).
Measured: Throughout pregnancy, an average of 9 months
Prevalence rate of live birth
The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.
Measured: At birth
Prevalence rate of preterm birth
Measured: At birth
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.
Measured: At birth
Prevalence rate of neonatal death
Measured: Within the first 28 days of life
Prevalence rate of infant death
Measured: Throughout the first year of life
Prevalence rate of postnatal growth deficiency
Weight, length or head circumference in <10th percentile for sex and age using standard growth charts.
Measured: Throughout the first year of life
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)
Measured: Throughout the first year of life
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)
Measured: Throughout the first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start28 Sep 2023
- Primary completion31 May 2032 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258902
- Sponsor's protocol ID
- A4250-017
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06258902
- Acronym / sponsor ID
- A4250-017
- Conditions
- Pregnancy Related
- Keywords
- Rare disease, PFIC, Pregnancy, Lactation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 May 2032 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Refusal to provide informed consent, if required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Prevalence rate of minor congenital malformations at birth
Time frame: At birth
Prevalence rate of molar or ectopic pregnancy
Time frame: Throughout pregnancy, an average of 9 months
Prevalence rate of fetal loss
Time frame: Throughout pregnancy, an average of 9 months
Prevalence rate of live birth
Time frame: At birth
Prevalence rate of preterm birth
Time frame: At birth
Prevalence rate of small for gestational age (SGA)
Time frame: At birth
Prevalence rate of neonatal death
Time frame: Within the first 28 days of life
Prevalence rate of infant death
Time frame: Throughout the first year of life
Prevalence rate of postnatal growth deficiency
Time frame: Throughout the first year of life
Prevalence rate of infant developmental delay
Time frame: Throughout the first year of life
Prevalence rate of infant hospitalization due to serious illness
Time frame: Throughout the first year of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Ipsen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ipsen Clinical Study Enquiries (See e mail, clinical.trials@ipsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence rate of major congenital malformations (MCM) at birth (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.