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NCT06297486

A Phase 3, Single-arm, Open-label, Multicenter Study of the Safety and Efficacy of Dirloctocogene Samoparvovec (SPK 8011, Adeno-associated Viral Vector With B-domain Deleted Human Factor VIII Gene) in Adults With Severe or Moderately Severe Hemophilia A

Study Summary

The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis.

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Interventions

SPK-8011GENETIC
Participants will receive a single dose of SPK-8011, administered by intravenous (IV) infusion, on Day 1.

Study Locations

FacilityCityStateCountry
Phoenix Children's HospitalPhoenixArizonaUnited States
Loma Linda University HealthLoma LindaCaliforniaUnited States
Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment CenterLos AngelesCaliforniaUnited States
Kaiser Permanente-Oakland Medical CenterOaklandCaliforniaUnited States
Kaiser Permanente-Roseville Medical CenterRosevilleCaliforniaUnited States
Kaiser Permanente -Sacramento Medical CenterSacramentoCaliforniaUnited States
Kaiser Permanente -San Francisco Medical CenterSan FranciscoCaliforniaUnited States
University of California - San FranciscoSan FranciscoCaliforniaUnited States
Kaiser Permanente- Santa Clara Medical CenterSanta ClaraCaliforniaUnited States
Kaiser Permanente-Vallejo Medical CenterVallejoCaliforniaUnited States
Kaiser Permanente -Walnut Creek Medical CenterWalnut CreekCaliforniaUnited States
University of FloridaGainesvilleFloridaUnited States
Boston Children's HospitalBostonMassachusettsUnited States
University of MinnesotaMinneapolisMinnesotaUnited States
Newark Beth IsraelNewarkNew JerseyUnited States
Weill Cornell Medical HospitalNew YorkNew YorkUnited States
University of North Carolina - Chapel HillChapel HillNorth CarolinaUnited States
Cincinnati Children's HospitalCincinnatiOhioUnited States
University Hospitals ClevelandClevelandOhioUnited States
Nationwide Children's HospitalColumbusOhioUnited States
Oregon Health & Sciences UniversityPortlandOregonUnited States
Penn State Hershey Medical CenterHersheyPennsylvaniaUnited States
University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States
Cook Children's HospitalFort WorthTexasUnited States
The University of Texas Health Science Center at Houston-Gulf States Hemophilia & Thrombosis CenterHoustonTexasUnited States
University of UtahSalt Lake CityUtahUnited States
Bloodworks NWSeattleWashingtonUnited States

Official Trial Information

View on ClinicalTrials.gov

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