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

NCT ID: NCT01968655

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Acquired Hemophilia A

Interventions

OBI-1

OBI-1 is a B domain deleted recombinant porcine factor VIII

Intervention Type: BIOLOGICAL

Other Intervention Names

B-Domain Deleted Recombinant Porcine Factor VIII

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxalta now part of Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

National Institutes of Health Warren G. Magnuson Clinical Center

Bethesda, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Penn State

Hershey, Pennsylvania, United States

Vanderbilt Hemostasis/Hemophilia Clinic

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

OBI-1-301a

Identifier Type: -

Identifier Source: org_study_id