Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replac… (NCT03876301) | Clinical Trial Compass
CompletedNot Applicable
Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants
United States25 participantsStarted 2019-01-21
Plain-language summary
The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe hemophilia A receiving prophylactic FVIII replacement therapy as standard of care. The data collected from this study may assist in providing baseline information for comparison to the Spark's investigational hemophilia A gene therapy in future Phase 3 studies.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Able and willing to provide written informed consent.
✓. Males ≥18 years of age.
✓. Clinically severe hemophilia A
✓. Previous exposure to FVIII therapy
✓. No prior history of hypersensitivity or anaphylaxis associated with an FVIII or intravenous immunoglobulin administration.
✓. No measurable inhibitor against FVIII
✓. Willing to participate and receive treatment in a future Spark hemophilia A gene therapy study.
Exclusion criteria
✕. Documented active hepatitis B or C within the past 12 months of Screening
✕. Currently on antiviral therapy to treat hepatitis B or C;
✕. Documented significant liver disease within the past 6 months of Screening
✕. Previously dosed with any investigational or approved gene therapy product at any time or treated with an investigational drug within the last 12 weeks;
✕. Planned surgical procedure in the next 12 months requiring FVIII prophylactic treatment.