[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06258902":3,"trial-entities:NCT06258902":103,"trial-summary:NCT06258902":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":17,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":36,"sex":69,"minimum_age":17,"maximum_age":17,"healthy_volunteers":17,"eligibility_criteria":70,"std_ages":77,"locations":81,"central_contacts":91,"overall_officials":97,"references":101,"see_also_links":102},"NCT06258902","A4250-017","Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and\u002For Lactation","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\u002For Lactation","RECRUITING","2032-05-31","2026-07","2026-08-03","2023-09-28","Ipsen","INDUSTRY",false,"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\u002For 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.",null,[19],"Pregnancy Related",[21,22,23,24],"Rare disease","PFIC","Pregnancy","Lactation","OBSERVATIONAL",[],{"count":28,"type":29},20,"ESTIMATED",[],[32],{"measure":33,"description":34,"timeFrame":35},"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",[37,39,43,46,49,51,54,57,60,63,66],{"measure":38,"timeFrame":35},"Prevalence rate of minor congenital malformations at birth",{"measure":40,"description":41,"timeFrame":42},"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",{"measure":44,"description":45,"timeFrame":42},"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).",{"measure":47,"description":48,"timeFrame":35},"Prevalence rate of live birth","The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.",{"measure":50,"timeFrame":35},"Prevalence rate of preterm birth",{"measure":52,"description":53,"timeFrame":35},"Prevalence rate of small for gestational age (SGA)","Birth weight \\\u003C10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.",{"measure":55,"timeFrame":56},"Prevalence rate of neonatal death","Within the first 28 days of life",{"measure":58,"timeFrame":59},"Prevalence rate of infant death","Throughout the first year of life",{"measure":61,"description":62,"timeFrame":59},"Prevalence rate of postnatal growth deficiency","Weight, length or head circumference in \\\u003C10th percentile for sex and age using standard growth charts.",{"measure":64,"description":65,"timeFrame":59},"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)",{"measure":67,"description":68,"timeFrame":59},"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)","FEMALE",{"inclusion":71,"exclusion":74,"raw_text":76},[72,73],"Exposure to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and\u002For at any time during lactation (up to 12 months of infant age or weaning, whichever comes first).","Informed consent or IRB-\u002FEC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices)",[75],"Refusal to provide informed consent, if required","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\u002For at any time during lactation (up to 12 months of infant age or weaning, whichever comes first).\n* Informed consent or IRB-\u002FEC-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",[78,79,80],"CHILD","ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program","Wilmington","North Carolina","28401","United States",{"lat":89,"lon":90},34.23556,-77.94604,[92],{"name":93,"role":94,"phone":95,"email":96},"Ipsen Clinical Study Enquiries","CONTACT","See e mail","clinical.trials@ipsen.com",[98],{"name":99,"affiliation":13,"role":100},"Ipsen Medical Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":107},[23,105,106],"Progressive Familial Intrahepatic Cholestasis","Weaning",[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an observational study with a planned enrollment of 20 women. It is not a randomized trial, and the phase is not specified.","completed","Odevixibat Safety During Pregnancy and Breastfeeding","This observational study is looking at the safety of odevixibat when taken during pregnancy or while breastfeeding. Researchers want to understand if taking odevixibat at any point from just before conception through pregnancy, or during breastfeeding (up to 12 months of the baby's age), is linked to major birth defects. You can join if you are a woman who has been exposed to odevixibat during these times. The study will collect information from you, your healthcare providers, and drug safety reports. This is an observational study, meaning your doctors will decide your care, not the study.","The primary outcome, major congenital malformations, is measured at birth.",96,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]