Overview

Russian Kogenate Pediatric Study

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
Male
Summary
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Factor VIII
Criteria
Inclusion Criteria:

- Male

- Severe hemophilia A or moderate hemophilia A

- 1-12 years of age

- Requiring treatment with FVIII

Exclusion Criteria:

- Current or prior inhibitor or familial antecedents of inhibitor

- Surgery required during the study (9 months)

- Positive for HIV