At a glance
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Randomized, Controlled, Parallel, Prospective Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects, as Applicable, Compared to That of Episodic Treatment
In Brief
A Phase 3 clinical trial evaluating Recombinant Factor VIII (Kogenate FS, BAY14-2222) for Hemophilia A. Completed, enrolled 84 participants across 38 sites in 4 countries.
Detailed Summary
To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding frequency (number of bleeds per year) and on joint damage.
Study Details
Timeline
Interventions
Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Treated according to the Kogenate FS package insert indications and study physician recommendations