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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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.
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.