drugset / Trial / NCT00632814

Russian Kogenate Pediatric Study

NCT00632814

Phase 4 Completed 32 enrolled Bayer
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-06
Primary completion
2009-09
Completion
2009-09

Publications

  • Results V.V. Vdovin, T.A. Andreeva, T.A. Chernova, F.G. Perina, E.E.M. Shiller, P.V. Svirin, M. Maas Enriquez, and S. Rauchensteiner. Prophylaxis with Once, Twice or Three-Times Weekly Dosing of rFVIII-FS Prevents Joint Bleeds in a Previously Treated Pediatric Population with Moderate/Severe Hemophilia A. Journal of Coagulation Disorders 2011; 3:(1). October 2011

Drugs

EvaluationDrugModalityDoseRoute
Subject ADVATE Protein / enzyme biologic 70 iu/kg Other
Subject ADVATE Protein / enzyme biologic 75 iu/kg Other

Indications