NCT03432520

A Multi-Center Evaluation of the Long-Term Safety and Efficacy of Spark-sponsored Gene Therapies in Males With Hemophilia A

Study Summary

This long-term follow-up study will continue to evaluate the long-term safety and efficacy of SPK-8011 and SPK-8016 in males with hemophilia A, who have received a single intravenous administration of SPK-8011 or SPK-8016 in any Spark-sponsored SPK-8011 or SPK-8016 study.

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Interventions

SPK-8011GENETIC
Observational long-term safety follow-up study of participants previously treated with SPK-8011 in any Spark-sponsored SPK-8011 study
SPK-8016GENETIC
Observational long-term safety follow-up study of participants previously treated with SPK-8016 in any Spark-sponsored SPK-8016 study

Study Locations

FacilityCityStateCountry
Boston Children's HospitalBostonMassachusettsUnited States
Mississippi Center for Advanced MedicineMadisonMississippiUnited States
Truman Medical CentersKansas CityMissouriUnited States
Oregon Health & Science UniversityPortlandOregonUnited States
Pennsylvania State University Milton S. Hershey Medical CenterHersheyPennsylvaniaUnited States
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Thomas Jefferson UniversityPhiladelphiaPennsylvaniaUnited States
Hemophilia Center of Western PennsylvaniaPittsburghPennsylvaniaUnited States
Virginia Commonwealth UniversityRichmondVirginiaUnited States
Royal Prince Alfred Hospital Department of Cell & Molecular TherapiesSydneyNew South WalesAustralia
The Alfred Hospital & Monash Medical CentreMelbourneVictoriaAustralia
St. Michael's HospitalTorontoOntarioCanada

Official Trial Information

View on ClinicalTrials.gov

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