OBI-1 Acquired Hemophilia Study
Research type
Research Study
Full title
Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies
IRAS ID
76638
Eudract number
2011-000181-34
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This study is testing whether the study drug (OBI-1) is effective and safe for the treatment of serious bleeding episodes in people with acquired hemophilia A. Acquired hemophilia A occurs when a patient??s body makes antibodies that inactivate factor VIII and as a result stop the blood from clotting. The study drug, OBI-1, is a blood clotting protein made from porcine factor VIII. This factor VIII is different from the human factor VIII, and it is expected that the antibodies that block human factor VIII will be less effective in blocking OBI-1. This study is being conducted in patients with acquired hemophilia A experiencing a serious bleeding episode. The study is open label, so all subjects will receive active treatment for their bleeds. Subjects will be treated in a hospital setting and the study drug will be given by infusion. Dosing is at the discretion of the investigator, and the amount and frequency of the dose given will be determined by the extent of the subject??s bleeding, their response to treatment, and their factor VIII blood levels. Unless the subject elects to withdraw consent or the treatment proves not to be effective for that subject, the treatment will continue until the bleeding is controlled and the bleed site is adequately healed. The subject??s response to the therapy will be regularly assessed by the investigator. Clinical evaluation of the bleed site and regular monitoring of blood factor VIII levels will contribute to the evaluation of the response. The primary measure of the treatment??s efficacy will be made 24 hours after the initial dose, by the investigator, using a well defined 3-point scale. There is an optional portion of the study during which blood is taken at regular intervals before and after the last dose to determine how long OBI-1 remains in the blood.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
11/NE/0130
Date of REC Opinion
23 Jun 2011
REC opinion
Further Information Favourable Opinion