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1 Study Matches

Dose-finding study of SPK-8016 gene therapy in patients with hemophilia A to support future evaluations in individuals with FVIII inhibitors.

SPK-8016-101 is a Phase 1/2a, open-label, non-randomized, dose-finding study designed to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with clinically severe hemophilia A and no measurable inhibitor against FVIII.
Cynthia Campbell-Baird, RN at cbaird@pennstatehealth.psu.edu or 717-531-5777
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03734588
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Inclusion Criteria:
Clinically severe Hemophilia A
Previous exposure to FVIII therapy
Have >150 exposure days to any recombinant and/or plasma-derived FVIII concentrates
No history of hypersensitivity or anaphylaxis with any FVIII or IV immunoglobulin product
No measurable inhibitor against FVIII
Exclusion Criteria:
Active Hepatitis B or C
Current use of antiviral therapy to treat Hepatitis B or C
Documented significant liver disease
Serological evidence of HIV-1 or HIV-2
Anti-AAV-Spark neutralizing antibody titers >1:5
Blood Disorders
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Location
Hershey, PA