Hemophilia A Clinical Trial
Official title:
Evaluate Efficacy and Safety of ADVATE in the Standard Prophylaxis Treatment of Severe or Moderately Severe Hemophilia A.
Hemophilia A is an X-linked recessive, congenital bleeding disorder caused by deficient or
defective coagulation factor VIII (FVIII). Prophylaxis is recommended as the standard of
care for boys with severe haemophilia by WHO and World Federation Of Hemophilia (WFH). The
efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with
hemophilia has been confirmed in well-designed clinical studies.To keep the factor level
above 1%, the standard dosage for patients with severe hemophilia A is 20-40 Units
/kg/infusion (average 30 Units /kg) every other day or three times a week. This dosage has a
very high consumption of factor, up to 5000-6000 international unit (IU)/kg/year. The high
consumption of factor and cost present a major barrier to use the standard prophylaxis in
many countries particularly in the developing world.
In China the majority of boys with severe hemophilia A can only pay for on-demand treatment
or low-dose prophylaxis. Ao after the affordability of patients was solved and many patients
will get more chance to receive standard prophylaxis.
This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and
QoL outcomes in subjects using ADVATE(Recombinant Human Coagulation Factor VIII for
injection) standard prophylaxis under the conditions of routine practice.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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