[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482952":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":11,"studyPopulation":11,"armGroups":56,"interventions":66,"overallOfficials":72,"centralContacts":76,"locations":81,"responsibleParty":442,"collaborators":11,"id":444,"slug":445,"hasResults":446,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":11,"eligibilityCriteria":450,"healthyVolunteers":446,"sex":451,"minAge":452,"maxAge":11,"enrollmentInfo":453,"targetDuration":11,"studyType":456,"phases":457,"briefSummary":459,"conditions":460,"keywords":463,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},{"fullName":5,"class":6},"Pfizer","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,16,18,20],{"measure":10,"description":11,"timeFrame":12},"Incidence of thromboembolic events",null,"Day 1 to 10 years",{"measure":14,"description":15,"timeFrame":12},"Incidence of factor inhibitor development","FIX inhibitor development was defined as an inhibitor titer \\>= 0.6 Bethesda units per milliliter (BU\u002FmL).",{"measure":17,"description":11,"timeFrame":12},"Incidence of hepatic malignancy",{"measure":19,"description":11,"timeFrame":12},"Incidence of liver abnormalities",{"measure":21,"description":22,"timeFrame":12},"Factor activity level","Factor activity level will be reported. Factor levels may be measured using different assay methods including a one-stage assay or by chromogenic substrate assay and a second one-stage assay.",[24,27,30,33,36,38,40,43,46],{"measure":25,"description":26,"timeFrame":12},"Total ABR (treated or untreated; (excluding bleeds related to surgery)","ABR (Annual Bleed Rate): number of bleeding episodes per year. This includes treated and untreated bleeds.\n\nThe ABR or the annualized number of bleeding episodes per year, will be derived for each participant for each observation period by using the following formula:\n\nABR = (Number of bleeds \u002F Days in observation period) x 365.25 days\u002Fyear.",{"measure":28,"description":29,"timeFrame":12},"Incidence of and time from vector infusion to resumption of prophylaxis","Describe incidence of resumption of prophylaxis resumption and the time (in days) to resumption of prophylaxis after receiving vector infusion.",{"measure":31,"description":32,"timeFrame":12},"AIR of exogenous factor (excluding infusions related to surgery)","The AIR or the annualized number of FIX infusions per year, will be derived for each participant for each observation period by using the following formula:\n\nAIR = (Number of FIX infusions \u002F Days in observation period) x 365.25 days\u002Fyear.",{"measure":34,"description":35,"timeFrame":12},"Consumption of exogenous factor (excluding infusions related to surgery)","The annualized TFC in international units (IU) will be derived for each participant for each observation period using the following formula:\n\nAnnualized TFC = (Total units of FIX infused (IU)\u002F Days in observation period) x 365.25 days\u002Fyear",{"measure":37,"description":11,"timeFrame":12},"Incidence of Non-hepatic malignancy",{"measure":39,"description":11,"timeFrame":12},"Incidence of Auto-immune disorders",{"measure":41,"description":42,"timeFrame":12},"Incidence of SAEs","An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability\u002Fincapacity; congenital anomaly; development of a clinical thrombotic event; development of factor inhibitor; development of a hepatic malignancy; development of drug-related elevated hepatic transaminases that fail to improve with immunosuppressive regimens; occurrence of a malignancy with reasonable possibility of being related to study drug.",{"measure":44,"description":45,"timeFrame":12},"All cause mortality","All-cause mortality was defined as the death due to any cause during the course of study. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort\u002Ftreatment group of interest. Incidence rate of all-cause deaths was reported in this outcome measure.",{"measure":47,"description":48,"timeFrame":12},"EQ-5D-5L dimension and VAS scores","The EQ-5D-5L comprises a 5-item health status measure and a visual analog rating scale\u002Ffeeling thermometer. Using the 5-dimensional Health State Classification, participants are asked to respond to five questions on different aspects of their health status that assess the following:\n\n1. Mobility\n2. Self-care\n3. Usual activities\n4. Pain\u002FDiscomfort\n5. Anxiety\u002FDepression",{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":11,"timePerspective":11,"maskingInfo":54},"NON_RANDOMIZED","SINGLE_GROUP","Non-investigational study","OTHER",{"masking":55,"maskingDescription":11,"whoMasked":11},"NONE",[57,62],{"label":58,"type":53,"description":59,"interventionNames":60},"Hemophilia A \u002F giroctocogene fitelparvovec","Participants have received treatment with giroctocogene fitelparvovec in a previous study and are not receiving any investigational product in this study",[61],"Diagnostic Test: Testing of hepatic AAV Vector integration",{"label":63,"type":53,"description":64,"interventionNames":65},"Hemophilia B \u002F fidanacogene elaparvovec","Participants have received treatment with fidanacogene elaparvovec in a previous study and are not receiving any investigational product in this study",[61],[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":11},"DIAGNOSTIC_TEST","Testing of hepatic AAV Vector integration","Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated",[58,63],[73],{"name":74,"affiliation":5,"role":75},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[77],{"name":74,"role":78,"phone":79,"phoneExt":11,"email":80},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[82,96,105,111,116,121,130,140,146,156,167,176,181,191,196,206,218,223,233,245,257,266,278,289,301,311,316,328,338,349,360,371,380,389,395,404,415,424,433],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":11},"The Regents of the University of California||UC Davis Health","RECRUITING","Rancho Cordova","California","95670","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-121.30273,38.58907,{"lat":94,"lon":93},{"facility":97,"status":84,"city":98,"state":86,"zip":99,"country":88,"countryCode":89,"cosmosGeoPoint":100,"geoPoint":104,"contacts":11},"UC Davis Health","Sacramento","95816",{"type":91,"coordinates":101},[102,103],-121.4944,38.58157,{"lat":103,"lon":102},{"facility":106,"status":84,"city":98,"state":86,"zip":107,"country":88,"countryCode":89,"cosmosGeoPoint":108,"geoPoint":110,"contacts":11},"UC Davis Ambulatory Care Clinic","95817",{"type":91,"coordinates":109},[102,103],{"lat":103,"lon":102},{"facility":112,"status":84,"city":98,"state":86,"zip":107,"country":88,"countryCode":89,"cosmosGeoPoint":113,"geoPoint":115,"contacts":11},"UC Davis Hemophilia Treatment Center",{"type":91,"coordinates":114},[102,103],{"lat":103,"lon":102},{"facility":117,"status":84,"city":98,"state":86,"zip":107,"country":88,"countryCode":89,"cosmosGeoPoint":118,"geoPoint":120,"contacts":11},"UC Davis Medical Center",{"type":91,"coordinates":119},[102,103],{"lat":103,"lon":102},{"facility":122,"status":84,"city":123,"state":86,"zip":124,"country":88,"countryCode":89,"cosmosGeoPoint":125,"geoPoint":129,"contacts":11},"UCSF Outpatient Hematology Clinic","San Francisco","94143",{"type":91,"coordinates":126},[127,128],-122.41942,37.77493,{"lat":128,"lon":127},{"facility":131,"status":84,"city":132,"state":133,"zip":134,"country":88,"countryCode":89,"cosmosGeoPoint":135,"geoPoint":139,"contacts":11},"USF Health Morsani Center For Advanced Healthcare","Tampa","Florida","33612",{"type":91,"coordinates":136},[137,138],-82.45843,27.94752,{"lat":138,"lon":137},{"facility":141,"status":84,"city":132,"state":133,"zip":142,"country":88,"countryCode":89,"cosmosGeoPoint":143,"geoPoint":145,"contacts":11},"The University of South Florida Board of Trustees","33620",{"type":91,"coordinates":144},[137,138],{"lat":138,"lon":137},{"facility":147,"status":84,"city":148,"state":149,"zip":150,"country":88,"countryCode":89,"cosmosGeoPoint":151,"geoPoint":155,"contacts":11},"Innovative Hematology, Inc.","Indianapolis","Indiana","46260",{"type":91,"coordinates":152},[153,154],-86.15804,39.76838,{"lat":154,"lon":153},{"facility":157,"status":158,"city":159,"state":160,"zip":161,"country":88,"countryCode":89,"cosmosGeoPoint":162,"geoPoint":166,"contacts":11},"Mississippi Center For Advanced Medicine","TERMINATED","Madison","Mississippi","39110",{"type":91,"coordinates":163},[164,165],-90.11536,32.46181,{"lat":165,"lon":164},{"facility":168,"status":84,"city":169,"state":169,"zip":170,"country":88,"countryCode":89,"cosmosGeoPoint":171,"geoPoint":175,"contacts":11},"Cornell University||Joan & Sanford I. Weill Medical College","New York","10065",{"type":91,"coordinates":172},[173,174],-74.00597,40.71427,{"lat":174,"lon":173},{"facility":177,"status":84,"city":169,"state":169,"zip":170,"country":88,"countryCode":89,"cosmosGeoPoint":178,"geoPoint":180,"contacts":11},"Weill Cornell Medical College-New York Presbyterian Hospital",{"type":91,"coordinates":179},[173,174],{"lat":174,"lon":173},{"facility":182,"status":84,"city":183,"state":184,"zip":185,"country":88,"countryCode":89,"cosmosGeoPoint":186,"geoPoint":190,"contacts":11},"The Childrens Hospital of Philadelphia Division of Hematology","Philadelphia","Pennsylvania","19104",{"type":91,"coordinates":187},[188,189],-75.16362,39.95238,{"lat":189,"lon":188},{"facility":182,"status":84,"city":183,"state":184,"zip":192,"country":88,"countryCode":89,"cosmosGeoPoint":193,"geoPoint":195,"contacts":11},"19146",{"type":91,"coordinates":194},[188,189],{"lat":189,"lon":188},{"facility":197,"status":84,"city":198,"state":199,"zip":200,"country":88,"countryCode":89,"cosmosGeoPoint":201,"geoPoint":205,"contacts":11},"Washington Institute for Coagulation","Seattle","Washington","98101",{"type":91,"coordinates":202},[203,204],-122.33207,47.60621,{"lat":204,"lon":203},{"facility":207,"status":84,"city":208,"state":209,"zip":210,"country":211,"countryCode":212,"cosmosGeoPoint":213,"geoPoint":217,"contacts":11},"Royal Prince Alfred Hospital","Camperdown","New South Wales","2050","Australia","AU",{"type":91,"coordinates":214},[215,216],151.17642,-33.88965,{"lat":216,"lon":215},{"facility":219,"status":84,"city":208,"state":209,"zip":210,"country":211,"countryCode":212,"cosmosGeoPoint":220,"geoPoint":222,"contacts":11},"Sydney Local Health District (RPAH Zone)",{"type":91,"coordinates":221},[215,216],{"lat":216,"lon":215},{"facility":224,"status":84,"city":225,"state":226,"zip":227,"country":211,"countryCode":212,"cosmosGeoPoint":228,"geoPoint":232,"contacts":11},"The Alfred Hospital","Melbourne","Victoria","3004",{"type":91,"coordinates":229},[230,231],144.96332,-37.814,{"lat":231,"lon":230},{"facility":234,"status":84,"city":235,"state":236,"zip":237,"country":238,"countryCode":239,"cosmosGeoPoint":240,"geoPoint":244,"contacts":11},"Unity Health Toronto, St. Michael's Hospital","Toronto","Ontario","M5B 1W8","Canada","CA",{"type":91,"coordinates":241},[242,243],-79.39864,43.70643,{"lat":243,"lon":242},{"facility":246,"status":84,"city":247,"state":248,"zip":249,"country":250,"countryCode":251,"cosmosGeoPoint":252,"geoPoint":256,"contacts":11},"Hospices Civils de Lyon - Hopital Louis Pradel","Bron","Rhône","69677","France","FR",{"type":91,"coordinates":253},[254,255],4.91303,45.73865,{"lat":255,"lon":254},{"facility":258,"status":84,"city":259,"state":11,"zip":260,"country":250,"countryCode":251,"cosmosGeoPoint":261,"geoPoint":265,"contacts":11},"Hôpital Universitaire Necker Enfants Malades","Paris","75015",{"type":91,"coordinates":262},[263,264],2.3488,48.85341,{"lat":264,"lon":263},{"facility":267,"status":84,"city":268,"state":269,"zip":270,"country":271,"countryCode":272,"cosmosGeoPoint":273,"geoPoint":277,"contacts":11},"Universitätsklinikum Bonn","Bonn","North Rhine-Westphalia","53127","Germany","DE",{"type":91,"coordinates":274},[275,276],7.09549,50.73438,{"lat":276,"lon":275},{"facility":279,"status":84,"city":280,"state":11,"zip":281,"country":282,"countryCode":283,"cosmosGeoPoint":284,"geoPoint":288,"contacts":11},"General Hospital of Athens Laiko","Athens","11527","Greece","GR",{"type":91,"coordinates":285},[286,287],23.72784,37.98376,{"lat":287,"lon":286},{"facility":290,"status":84,"city":291,"state":292,"zip":293,"country":294,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":11},"Nagoya University Hospital","Nagoya","Aichi-ken","466-8560","Japan","JP",{"type":91,"coordinates":297},[298,299],136.90641,35.18147,{"lat":299,"lon":298},{"facility":302,"status":84,"city":303,"state":304,"zip":305,"country":294,"countryCode":295,"cosmosGeoPoint":306,"geoPoint":310,"contacts":11},"Sapporo Tokushukai Hospital","Sapporo","Hokkaido","004-0041",{"type":91,"coordinates":307},[308,309],141.35,43.06667,{"lat":309,"lon":308},{"facility":312,"status":84,"city":313,"state":314,"zip":315,"country":294,"countryCode":295,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Saitama Medical University Hospital","Iruma-gun","Saitama","350-0495",{"facility":317,"status":318,"city":319,"state":11,"zip":320,"country":321,"countryCode":322,"cosmosGeoPoint":323,"geoPoint":327,"contacts":11},"King Faisal Specialist Hospital and Research Center","NOT_YET_RECRUITING","Riyadh","11211","Saudi Arabia","SA",{"type":91,"coordinates":324},[325,326],46.72185,24.68773,{"lat":326,"lon":325},{"facility":329,"status":84,"city":330,"state":11,"zip":331,"country":332,"countryCode":11,"cosmosGeoPoint":333,"geoPoint":337,"contacts":11},"Kyung Hee University Hospital at Gangdong","Seoul","05278","South Korea",{"type":91,"coordinates":334},[335,336],126.9784,37.566,{"lat":336,"lon":335},{"facility":339,"status":84,"city":340,"state":11,"zip":341,"country":342,"countryCode":343,"cosmosGeoPoint":344,"geoPoint":348,"contacts":11},"Hospital Universitario Rio Hortega","Valladolid","47012","Spain","ES",{"type":91,"coordinates":345},[346,347],-4.72353,41.65541,{"lat":347,"lon":346},{"facility":350,"status":84,"city":351,"state":11,"zip":352,"country":353,"countryCode":354,"cosmosGeoPoint":355,"geoPoint":359,"contacts":11},"Skåne University Hospital","Malmö","21428","Sweden","SE",{"type":91,"coordinates":356},[357,358],13.00073,55.60587,{"lat":358,"lon":357},{"facility":361,"status":84,"city":362,"state":11,"zip":363,"country":364,"countryCode":365,"cosmosGeoPoint":366,"geoPoint":370,"contacts":11},"Changhua Christian Hospital","Changhua","500","Taiwan","TW",{"type":91,"coordinates":367},[368,369],120.5512,24.0692,{"lat":369,"lon":368},{"facility":372,"status":84,"city":373,"state":11,"zip":374,"country":364,"countryCode":365,"cosmosGeoPoint":375,"geoPoint":379,"contacts":11},"Chung-Ho Memorial Hospital, Kaohsiung Medical University","Kaohsiung City","807",{"type":91,"coordinates":376},[377,378],120.31333,22.61626,{"lat":378,"lon":377},{"facility":381,"status":318,"city":382,"state":11,"zip":383,"country":364,"countryCode":365,"cosmosGeoPoint":384,"geoPoint":388,"contacts":11},"Chung Shan Medical University Hospital","Taichung","402",{"type":91,"coordinates":385},[386,387],120.6839,24.1469,{"lat":387,"lon":386},{"facility":390,"status":84,"city":382,"state":11,"zip":391,"country":364,"countryCode":365,"cosmosGeoPoint":392,"geoPoint":394,"contacts":11},"Taichung Veterans General Hospital","40705",{"type":91,"coordinates":393},[386,387],{"lat":387,"lon":386},{"facility":396,"status":84,"city":397,"state":11,"zip":398,"country":364,"countryCode":365,"cosmosGeoPoint":399,"geoPoint":403,"contacts":11},"National Taiwan University Hospital","Taipei","10041",{"type":91,"coordinates":400},[401,402],121.52639,25.05306,{"lat":402,"lon":401},{"facility":405,"status":84,"city":406,"state":407,"zip":408,"country":409,"countryCode":11,"cosmosGeoPoint":410,"geoPoint":414,"contacts":11},"Ege Universitesi Hastanesi","Izmir","İ̇zmir","35100","Turkey (Türkiye)",{"type":91,"coordinates":411},[412,413],27.13838,38.41273,{"lat":413,"lon":412},{"facility":416,"status":84,"city":417,"state":11,"zip":418,"country":409,"countryCode":11,"cosmosGeoPoint":419,"geoPoint":423,"contacts":11},"Acibadem Adana Hospital","Adana","01130",{"type":91,"coordinates":420},[421,422],35.32531,36.98615,{"lat":422,"lon":421},{"facility":425,"status":84,"city":426,"state":11,"zip":427,"country":409,"countryCode":11,"cosmosGeoPoint":428,"geoPoint":432,"contacts":11},"Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi","Gaziantep","27310",{"type":91,"coordinates":429},[430,431],37.3825,37.05944,{"lat":431,"lon":430},{"facility":434,"status":84,"city":435,"state":11,"zip":436,"country":409,"countryCode":11,"cosmosGeoPoint":437,"geoPoint":441,"contacts":11},"İstanbul Üniversitesi Onkoloji Enstitüsü","Istanbul","34093",{"type":91,"coordinates":438},[439,440],28.94966,41.01384,{"lat":440,"lon":439},{"type":443,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100482952","phase-3-safety-and-effectiveness-of-giroctocogene-fitelparvovec-or-fidanacogene-elaparvovec-in-patients-with-hemophilia-a-or-b-respectively-100482952",false,"NCT05568719","Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively","A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY","Inclusion Criteria:\n\n-Only participants who received investigational giroctocogene fitelparvovec or fidanacogene eleparvovec and were enrolled in a Pfizer-sponsored study (C0371002, C0371003, C0371005, C3731001, C3731003) are eligible.\n\nExclusion Criteria:\n\n-None","MALE","18 Years",{"count":454,"type":455},173,"ESTIMATED","INTERVENTIONAL",[458],"PHASE3","A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.",[461,462],"Hemophilia A","Hemophilia B",[464,465,466,467,468,469,470],"bleeding","adeno-associated virus based vector","gene therapy","giroctocogene fitelparvovec","fidanacogene elaparvovec","factor VIII","factor IX","2026-10-06",{"date":473,"type":474},"2026-10-07","ACTUAL",{"date":476,"type":474},"2022-12-28",{"date":478,"type":455},"2040-02-25",{"name":5,"class":6},39]