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NCT05568719

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

Study Summary

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.

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Interventions

Testing of hepatic AAV Vector integrationDIAGNOSTIC_TEST
Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated

Study Locations

FacilityCityStateCountry
The Regents of the University of California||UC Davis HealthRancho CordovaCaliforniaUnited States
UC Davis HealthSacramentoCaliforniaUnited States
UC Davis Ambulatory Care ClinicSacramentoCaliforniaUnited States
UC Davis Hemophilia Treatment CenterSacramentoCaliforniaUnited States
UC Davis Medical CenterSacramentoCaliforniaUnited States
UCSF Outpatient Hematology ClinicSan FranciscoCaliforniaUnited States
USF Health Morsani Center For Advanced HealthcareTampaFloridaUnited States
The University of South Florida Board of TrusteesTampaFloridaUnited States
Innovative Hematology, Inc.IndianapolisIndianaUnited States
Mississippi Center For Advanced MedicineMadisonMississippiUnited States
Cornell University||Joan & Sanford I. Weill Medical CollegeNew YorkNew YorkUnited States
Weill Cornell Medical College-New York Presbyterian HospitalNew YorkNew YorkUnited States
The Childrens Hospital of Philadelphia Division of HematologyPhiladelphiaPennsylvaniaUnited States
The Childrens Hospital of Philadelphia Division of HematologyPhiladelphiaPennsylvaniaUnited States
Washington Institute for CoagulationSeattleWashingtonUnited States
Royal Prince Alfred HospitalCamperdownNew South WalesAustralia
Sydney Local Health District (RPAH Zone)CamperdownNew South WalesAustralia
The Alfred HospitalMelbourneVictoriaAustralia
Unity Health Toronto, St. Michael's HospitalTorontoOntarioCanada
Hospices Civils de Lyon - Hopital Louis PradelBronRhôneFrance
Hôpital Universitaire Necker Enfants MaladesParisFrance
Universitätsklinikum BonnBonnNorth Rhine-WestphaliaGermany
General Hospital of Athens LaikoAthensGreece
Nagoya University HospitalNagoyaAichi-kenJapan
Sapporo Tokushukai HospitalSapporoHokkaidoJapan
Saitama Medical University HospitalIruma-gunSaitamaJapan
King Faisal Specialist Hospital and Research CenterRiyadhSaudi Arabia
Kyung Hee University Hospital at GangdongSeoulSouth Korea
Hospital Universitario Rio HortegaValladolidSpain
Skåne University HospitalMalmöSweden
Changhua Christian HospitalChanghuaTaiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical UniversityKaohsiung CityTaiwan
Chung Shan Medical University HospitalTaichungTaiwan
Taichung Veterans General HospitalTaichungTaiwan
National Taiwan University HospitalTaipeiTaiwan
Ege Universitesi HastanesiIzmirİ̇zmirTurkey (Türkiye)
Acibadem Adana HospitalAdanaTurkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama HastanesiGaziantepTurkey (Türkiye)
İstanbul Üniversitesi Onkoloji EnstitüsüIstanbulTurkey (Türkiye)

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: October 12, 2026