NCT03061201

A PHASE 1/2, OPEN-LABEL, ADAPTIVE, DOSE-RANGING STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF SB-525 (PF-07055480) (RECOMBINANT AAV2/6 HUMAN FACTOR 8 GENE THERAPY) IN ADULT SUBJECTS WITH SEVERE HEMOPHILIA A

Study Summary

The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)

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Interventions

SB-525 (PF-07055480)BIOLOGICAL
Single dose of investigational product SB-525 (PF-07055480)

Study Locations

FacilityCityStateCountry
Arkansas Children's HospitalLittle RockArkansasUnited States
City of Hope Medical CenterDuarteCaliforniaUnited States
Midtown Ambulatory Care CenterSacramentoCaliforniaUnited States
UC Davis Ambulatory Care ClinicSacramentoCaliforniaUnited States
UC Davis Comprehensive Cancer CenterSacramentoCaliforniaUnited States
UC Davis CTSC Clinical Research CenterSacramentoCaliforniaUnited States
UC Davis Hemophilia Treatment CenterSacramentoCaliforniaUnited States
UC Davis Investigational Drug Services PharmacySacramentoCaliforniaUnited States
UC Davis Medical CenterSacramentoCaliforniaUnited States
University of California, San Francisco - Investigational Drug Service (IDS) PharmacySan FranciscoCaliforniaUnited States
University of California, San Francisco - Outpatient Hematology ClinicSan FranciscoCaliforniaUnited States
University of California, San Francisco -Moffitt HospitalSan FranciscoCaliforniaUnited States
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer CenterMiamiFloridaUnited States
USF Health Morsani Center For Advanced HealthcareTampaFloridaUnited States
Emory University School of MedicineAtlantaGeorgiaUnited States
Hemophilia Center of Western PAPittsburghPennsylvaniaUnited States
UPMC Montefiore Clinical and Translational Research CenterPittsburghPennsylvaniaUnited States
UPMC, Investigational Drug ServicePittsburghPennsylvaniaUnited States
Vanderbilt University Medical Center Clinical Research CenterNashvilleTennesseeUnited States
Vanderbilt Hemostasis Treatment ClinicNashvilleTennesseeUnited States
Vanderbilt Hemostasis-Thrombosis ClinicNashvilleTennesseeUnited States
Washington Institute for CoagulationSeattleWashingtonUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026