Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A

Inclusion Criteria:

• Males or females ≥18 years of age.
• Written informed consent from subject.
• Subjects with acquired hemophilia with autoimmune inhibitory antibodies to human factor VIII
• Has a serious bleeding episode, as documented by the investigator.
• Be willing and able to follow all instructions and attend all study visits.
• Subjects taking anti-thrombotics may be included depending on time elapsed since taking such medications
• Life expectancy, before bleed, of at least 90 days.

Exclusion Criteria:

• Hemodynamically unstable
• Has an established reason for bleeding that is not correctable.
• Bleeding episode assessed likely to resolve on its own if left untreated.
• Anti-OBI-1 inhibitor that exceeds 20 BU
• Prior history of bleeding disorder other than acquired hemophilia.
• Known major sensitivity to pig or hamster products.
• Use of hemophilia medication within 3 to 6 (depending on medication) hours prior to OBI-1 administration
• Participation in any other clinical study within 30 days of the first OBI-1 treatment.
• Anticipated need for treatment or device during the study that may interfere with the evaluation
• Is currently pregnant or planning to become pregnant or father a child during the study
• Abnormal baseline findings
• Inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures.