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

Completed · Phase 2

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT00245245

Run by

Octagen Corporation

People needed

12

Starts

2005-05-01

Expected to finish

2007-06-01

Last updated by the study team

2007-10-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Octagen Corporation — Blue Bell, Pennsylvania, United States

Full record on ClinicalTrials.gov

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