An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

Inclusion Criteria:

• Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

Exclusion Criteria:

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