The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII \< 1%). The observational period will cover at least 5 years per patient. The long-term secondary prophylaxis group will be compared versus on-demand treatment group by the assessment of orthopedic status progression and pharmacoeconomics evaluation.
Study Type
OBSERVATIONAL
Enrollment
58
Long-term secondary prophylaxis with product administered 20-30 UI /kg three times weekly
On-demand treatment with product given only for bleeding episodes
Unnamed facility
Many Locations, Italy
Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year
Time frame: Every 6 months
Efficacy, safety, pharmacoeconomic impact of secondary prophylaxis versus on demand group in terms of overall bleeding episodes
Time frame: Every 6 months
Muscolo skeletal evaluation by Orthopedic Joint Score
Time frame: Every 12 months
Radiological Evaluation by Pettersson Score
Time frame: Baseline and after 3-5 years
Health related quality of life
Time frame: Every 12 months
cost-effectiveness and utility, patient compliance, adverse events
Time frame: Every 6 months
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