Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of A… (NCT01968655) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
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
United States
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…