Status:
COMPLETED
Study of Recombinant Porcine Factor VIII (FVIII) in Hemophilia and Inhibitors to FVIII
Lead Sponsor:
Octagen Corporation
Collaborating Sponsors:
Biomeasure Inc, Ipsen Group
Conditions:
Hemophilia A
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The primary objective of the study is to evaluate the hemostatic activity of OBI-1 to control a bleeding episode in hemophilia A patients with inhibitors who are experiencing a non-life and/or non-lim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00245245
Start Date
May 1 2005
End Date
June 1 2007
Last Update
October 4 2007
Active Locations (1)
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1
Octagen Corporation
Blue Bell, Pennsylvania, United States, 19422