Study of Recombinant Porcine Factor VIII (FVIII) in Hemophilia and Inhibitors to FVIII

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octagen Corporation
• Collaborator: Biomeasure Inc, Ipsen Group
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

Patients must meet at least the following criteria to participate in the trial:

• Age at least 12 years.

• Clinical diagnosis of congenital hemophilia A with current inhibitor to human fVIII OR the patient is known to have developed an anti-human fVIII inhibitor antibody anamnestic response to human fVIII in the past.

• OBI-1 inhibitor antibody titer < 20 Bethesda Units at screening.

• Uncomplicated joint or soft tissue bleed, or other non-life threatening or non-limb threatening bleeding episode.

Exclusion Criteria:

Patients will be ineligible to participate if any of the following are present:

• Current treatment plan for any acute bleeding episode incorporates the use of human fVIII (recombinant or plasma-derived).

• Presence of any life- or limb-threatening bleeding episode (defined)

• Patient has received any human fVIII or prothrombin complex concentrate (PCC), within 7 days prior to Screening, OR received any PCC within 7 days prior to treatment with OBI-1.

• Patient has received recombinant human fVIIa (rVIIa) within 3 days prior to Screening OR within 3 days prior to treatment with OBI-1.

• Significant liver disease or renal disease