Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors

Study Summary

SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with severe hemophilia A and no measurable inhibitor against FVIII.

Interventions

Study Locations

Facility	City	State	Country
Orthopaedic Institute for Children	Los Angeles	California	United States
Illinois Bleeding and Clotting Disorders Institute	Peoria	Illinois	United States
University of Michigan	Ann Arbor	Michigan	United States
Mississippi Center for Advanced Medicine	Madison	Mississippi	United States
Weill Cornell Medicine	New York	New York	United States
Oregon Health & Science University	Portland	Oregon	United States
Penn State Health	Hershey	Pennsylvania	United States
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States
Jefferson University Hospitals	Philadelphia	Pennsylvania	United States
Hemophilia Center of Western Pennsylvania	Pittsburgh	Pennsylvania	United States
Virginia Commonwealth University School of Medicine	Richmond	Virginia	United States

Official Trial Information

View on ClinicalTrials.gov