Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT06258902
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D035583', 'term': 'Rare Diseases'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence rate of major congenital malformations (MCM) at birth', 'timeFrame': 'At birth', 'description': '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.'}], 'secondaryOutcomes': [{'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', 'description': '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.'}, {'measure': 'Prevalence rate of fetal loss', 'timeFrame': 'Throughout pregnancy, an average of 9 months', 'description': '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).'}, {'measure': 'Prevalence rate of live birth', 'timeFrame': 'At birth', 'description': 'The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.'}, {'measure': 'Prevalence rate of preterm birth', 'timeFrame': 'At birth'}, {'measure': 'Prevalence rate of small for gestational age (SGA)', 'timeFrame': 'At birth', 'description': 'Birth weight \\<10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.'}, {'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', 'description': 'Weight, length or head circumference in \\<10th percentile for sex and age using standard growth charts.'}, {'measure': 'Prevalence rate of infant developmental delay', 'timeFrame': 'Throughout the first year of life', 'description': 'Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC)'}, {'measure': 'Prevalence rate of infant hospitalization due to serious illness', 'timeFrame': 'Throughout the first year of life', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rare disease', 'PFIC', 'Pregnancy', 'Lactation'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nStudy start date is either start of data collection or first patient enrolled whatever occurs earlier.\n\nThe 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.\n\nNo additional laboratory tests or HCP assessments will be required as part of this surveillance program."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'genderDescription': 'Child-bearing potential women: individuals of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy and/or lactation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n* Informed consent or IRB-/EC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices)\n\nExclusion Criteria:\n\n* Refusal to provide informed consent, if required'}, 'identificationModule': {'nctId': 'NCT06258902', 'briefTitle': 'Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'A4250-017'}}, 'contactsLocationsModule': {'locations': [{'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'centralContacts': [{'name': 'Ipsen Clinical Study Enquiries', 'role': 'CONTACT', 'email': 'clinical.trials@ipsen.com', 'phone': 'See e mail'}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.', 'ipdSharing': 'YES', 'description': '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.\n\nPatient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.', 'accessCriteria': "Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}