Acquired Hemophilia A
Conditions
Keywords
Factor VIII Inhibitory Auto-antibodies
Brief summary
To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the OBI-1-301 study.
Interventions
BIOLOGICALOBI-1
OBI-1 is a B domain deleted recombinant porcine factor VIII
Sponsors
Baxalta now part of Shire
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Countries
United States
Outcome results
None listed