Study of Recombinant Porcine Factor VIII (FVIII) in Hemophilia and Inhibitors to FVIII
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
The ability of a new recombinant porcine coagulation factor VIII, B-domain deleted (called
"OBI-1"), to control the non-life- or limb-threatening bleeding episodes patients with
hemophilia A commonly develop is being evaluated. Patients with congenital hemophilia A and a
low-titer (<20 Bethesda units [Bu]) inhibitory antibody to OBI-1, who meet the
inclusion/exclusion criteria, will receive OBI-1 to treat their soft tissue or joint bleeding
episode. At least the first two treatment episodes will be performed in the controlled
setting of the hemophilia center/clinic/office, where any side effects can be observed. If
the patient continues to meet the inclusion/exclusion criteria, has had no serious or severe
adverse reactions to OBI-1, and has been in a home care program, the investigator may permit
the patient to self-administer OBI-1 at home to treat subsequent bleeding episodes. The study
will continue at least until 12 or more patients have received at least 24 treatment episodes
in the aggregate.