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