Clinical trial: Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies (NCT01968655)

Eligibility criteria:
Inclusion Criteria:

          -  Written informed consent from participant or their legal representative.

          -  Participants with acquired hemophilia with autoimmune inhibitors 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.

          -  Participants taking anti-thrombotics may be included depending on the time elapsed
             since taking such medications.

          -  Life expectancy of at least 90 days prior to the onset of the bleeding episode.

        Exclusion Criteria:

          -  Hemodynamically unstable after blood transfusion, fluid resuscitation and
             pharmacologic or volume replacement pressor therapy.

          -  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 (prospectively or retrospectively).

          -  Subsequent bleeding episode at the site of the initial qualifying bleeding episode
             within 2 weeks following the final OBI-1 dose for the initial qualifying bleeding
             episode, or subsequent bleeding episode at a different site than the initial
             qualifying bleeding episode within 1 week following the final OBI-1 dose for the
             initial qualifying bleeding episode will not be considered "new" qualifying bleeding
             episodes.

          -  Prior history of bleeding disorder other than acquired hemophilia.

          -  Known major sensitivity (anaphylactoid reactions) 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.

          -  Abnormal baseline findings

          -  Inability or unwillingness to comply with the study design, protocol requirements, or
             the follow-up procedures.
No condition on gender to be admitted to the trial.

Subject must be at least 18 Years old.


Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction