[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06660342":3,"trial-entities:NCT06660342":105,"trial-summary:NCT06660342":110},{"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":23,"study_type":27,"primary_purpose":17,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":43,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":83,"locations":86,"central_contacts":96,"overall_officials":102,"references":103,"see_also_links":104},"NCT06660342","VONO-402","A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring","Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring","RECRUITING","2034-09","2025-05","2025-05-22","2025-05-15","Phathom Pharmaceuticals, Inc.","INDUSTRY",false,"The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.",null,[19,20,21,22],"Erosive Esophagitis","Heartburn","Symptomatic Non-erosive Gastroesophageal Reflux Disease","Helicobacter Pylori Infection",[19,20,21,22,24,25,26],"Pregnant Women","Fetal","Infant","OBSERVATIONAL",[],{"count":30,"type":31},728,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Vonoprazan","Oral tablet.",[38],"Exposed Cohort",[40],{"measure":41,"timeFrame":42},"Number of Participants with Major Congenital Malformations (MCMs)","Date of conception (DOC) to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births",[44,47,50,53,56,59,62,65],{"measure":45,"timeFrame":46},"Number of Participants with Minor Congenital Malformations","DOC to pregnancy outcome for fetal losses (approximately 40 gestational weeks) or 12 months from birth for live births",{"measure":48,"timeFrame":49},"Number of Participants who Experience Spontaneous Abortion (SAB)","DOC to 19 gestational weeks",{"measure":51,"timeFrame":52},"Number of Participants who Experience Stillbirth","20 gestational weeks to pregnancy outcome (approximately 40 weeks)",{"measure":54,"timeFrame":55},"Number of Participants who Experience Elective Termination","DOC to pregnancy outcome (approximately 40 weeks)",{"measure":57,"timeFrame":58},"Number of Participants who Experience Preterm Birth","DOC to 36 gestational weeks",{"measure":60,"timeFrame":61},"Number of Participants who are Small for Gestational Age (SGA)","At delivery of live birth (approximately 40 weeks)",{"measure":63,"timeFrame":64},"Number of Participants who Experience Postnatal Growth Deficiency","4 Months and 12 Months from Birth",{"measure":66,"timeFrame":64},"Number of Participants who Experience Infant Developmental Delay","FEMALE","15 Years","50 Years",{"inclusion":71,"exclusion":78,"raw_text":82},[72,73,74,75,76,77],"Women 15 to 50 years of age.","Currently or recently pregnant.","Consent to participate.","Authorization for her health care provider(s) (HCP\\[s\\]) to provide data to the registry.","Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.","Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.",[79,80,81],"Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).","Exposure to known tetratogens and\u002For investigational medications during pregnancy.","Lost to follow-up.","Inclusion Criteria:\n\n* Women 15 to 50 years of age.\n* Currently or recently pregnant.\n* Consent to participate.\n* Authorization for her health care provider(s) (HCP\\[s\\]) to provide data to the registry.\n* Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.\n* Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.\n\nExclusion Criteria:\n\n* Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).\n* Exposure to known tetratogens and\u002For investigational medications during pregnancy.\n* Lost to follow-up.",[84,85],"CHILD","ADULT",[87],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"PPD","Wilmington","North Carolina","28401","United States",{"lat":94,"lon":95},34.23556,-77.94604,[97],{"name":98,"role":99,"phone":100,"email":101},"VOQUEZNA Pregnancy Registry","CONTACT","1-866-609-1612","DLVOQUEZNAPregnancyRegistry@ppd.com",[],[],[],{"nct_id":4,"conditions":106,"biomarkers":109},[107,108,20,22],"Erosive esophagitis","Gastroesophageal Reflux Disease",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an observational study, meaning researchers will watch and collect information from participants rather than giving them a specific treatment. It aims to enroll 728 women.","completed","Observational Study of Vonoprazan Exposure During Pregnancy","This study is looking at the safety of a medication called vonoprazan when taken by pregnant women. Vonoprazan is used to treat conditions like heartburn and acid reflux (erosive esophagitis, symptomatic non-erosive gastroesophageal reflux disease), and H. pylori infection. Researchers want to compare the health of mothers and their babies who took vonoprazan during pregnancy with those who didn't take vonoprazan but had similar conditions. The main goal is to see how many babies have major birth defects (major congenital malformations) in both groups. You can join if you are a woman between 15 and 50 years old, are currently or recently pregnant, and agree to share your health information. The study aims to include 728 participants, but its current status is unclear.","The study will track major birth defects from the date of conception until pregnancy outcome for fetal losses, or for 12 months after birth for live births.",123,"You would need to consent to participate and authorize your healthcare provider(s) to share your health data with the study.","Not stated in the trial record.",[35],"v2"]