Hemophilia Clinical Trial
Official title:
Evaluation of Efficacy, Safety and Costs of Recombinant FVIII Products Applied to Severe Hemophilia A Patients: Observational Data Collection Study Evaluating On-demand Treatment and Secondary Prophylaxis
The project is an observational, multi-central, prospective, non-interventional and
open-label data collection study on secondary prophylaxis with recombinant FVIII products in
adolescents and adults with severe hemophilia A (FVIII < 1%).
It will be a controlled observation of patients on secondary prophylaxis versus on-demand
treatment regimen. Patients will be enrolled preferably on a 1:1 basis with regards to
prophylaxis and on-demand treatment.
The patient enrollment period will be 2 years with a follow-up (observation period) of 2
years for each patient. Based on the primary effectiveness parameters (joint bleeds and
overall bleeds per year) an observation period of 2 years is considered sufficient although
it has to be admitted that it is rather short to assess the progression of orthopedic status.
Previously treated prophylaxis patients with at least 50 exposure days and patients with
continuing prophylaxis treatment will be included.
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