Clinical trial NCT01968655: 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
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Acquired Hemophilia A
Keywords: Factor VIII Inhibitory Auto-antibodies
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-10-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Warren G. Magnuson Clinical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Hershey
country: United States
facility: Penn State
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Hemostasis/Hemophilia Clinic
state: Tennessee
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: