Refine your search

Search Results

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

1 Study Matches

Gene-transfer, open-label, dose-escalation study of SPK-8011 [recombinant adeno-associated viral vector with B-domain deleted human factor VIII gene] in individuals with hemophilia A

Gene-transfer, open-label, dose-escalation study of SPK-8011 in individuals with hemophilia A. Primary Objective to evaluate the safety, tolerability and efficacy of SPK-8011 a recombinant adeno-associated viral vector with B-domain deleted human factor VIII gene.
Cynthia Campbell-Baird at cbaird@pennstatehealth.psu.edu or 717-531-5777
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03003533
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Hemophilia A
FVIII Level <1% or 1-2% with> 10 bleeds past 52 weeks or 1-2% on prophy treatment
Greater than 150 exposure days to Factor VIII concentrate or cryo
No evidence of Factor VIII Inhibitor
Acceptable lab values as defined by protocol
Exclusion Criteria:
Active Hep B or C &/or current antiviral therapy for Hep B or C
Significant underlying liver disease, cancer, GI disease, latent infectious disease
HIV-1 or HIV-2 with CD4 count </=l to 200
Other investigational product in the past 12 weeks or gene therapy research within the past 52 weeks
Any other significant condition/disease that in the opinion of the investigator would make the subject unsuuitable
Blood Disorders
  Email this study information to me
  Contact the study team
  See more information
  Show all 1 locations

Study Locations

Hide all locations
Location
Hershey, PA