[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100188778":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":11,"centralContacts":15,"locations":23,"responsibleParty":38,"collaborators":40,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":10,"eligibilityCriteria":103,"healthyVolunteers":100,"sex":104,"minAge":10,"maxAge":10,"enrollmentInfo":105,"targetDuration":108,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":10,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Pregnant Patients Exposed to Mycophenolate",null,[12],{"name":13,"affiliation":5,"role":14},"Clinical Trials","STUDY_DIRECTOR",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Reference Study ID Number: ML22679 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":22,"role":18,"phone":10,"phoneExt":10,"email":10},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[24],{"facility":25,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":10},"Quintiles Outcome","RECRUITING","Cambridge","Massachusetts","02139","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-71.10561,42.3751,{"lat":36,"lon":35},{"type":39,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[41,43,45,48,50,52,54,56,58,60,62,64,66,68,70,72,74,76,78,80,82,84,86,88,90,92,94,96],{"name":42,"class":6},"Accord Healthcare, Inc.",{"name":44,"class":6},"Alkem Laboratories Ltd",{"name":46,"class":47},"Ascend Laboratories, LLC","UNKNOWN",{"name":49,"class":6},"Amneal Pharmaceuticals, LLC",{"name":51,"class":47},"Amta labs Limited",{"name":53,"class":6},"Apotex Inc.",{"name":55,"class":47},"Avet Lifesciences Limited",{"name":57,"class":6},"Azurity Pharmaceuticals",{"name":59,"class":47},"Biocon Pharma Limited",{"name":61,"class":47},"Concord Biotech Limited",{"name":63,"class":6},"Endo USA Inc., a Keenova Therapeutics Company",{"name":65,"class":47},"Hetero Labs Limited, Unit-V",{"name":67,"class":6},"Hikma Pharmaceuticals USA Inc.",{"name":69,"class":47},"Hisun Pharmaceuticals",{"name":71,"class":47},"Jubilant Cadista Pharmaceuticals, Inc.",{"name":73,"class":6},"Lannett Company, Inc.",{"name":75,"class":6},"Meitheal Pharmaceuticals, Inc.",{"name":77,"class":6},"Mylan Pharmaceuticals Inc",{"name":79,"class":6},"Novartis Pharmaceuticals",{"name":81,"class":47},"Rising Pharma Holdings, Inc.",{"name":83,"class":47},"RK Pharma Inc.",{"name":85,"class":6},"Sandoz",{"name":87,"class":47},"Strides Pharma, Inc",{"name":89,"class":6},"Teva Pharmaceuticals USA",{"name":91,"class":47},"TWi Pharmaceuticals, Inc.",{"name":93,"class":6},"VistaPharm, Inc.",{"name":95,"class":47},"Wuxi Fortune Pharmaceutical Co., Ltd",{"name":97,"class":47},"Zydus Pharmaceuticals","100188778","the-mycophenolate-pregnancy-registry-100188778",false,"NCT01733082","The Mycophenolate Pregnancy Registry","Inclusion Criteria:\n\n* Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment\n\nExclusion Criteria:\n\n* Pregnancies for which there is paternal exposure only\n* Pregnancies occurring outside the U.S.","FEMALE",{"count":106,"type":107},500,"ESTIMATED","2 Years","OBSERVATIONAL","The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified.\n\nThis is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.",[112],"Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases","2026-06-11",{"date":115,"type":116},"2026-06-15","ACTUAL",{"date":118,"type":116},"2012-11-20",{"date":120,"type":107},"2040-12-31",{"name":5,"class":6},1]