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

Acquired Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01968655
• Other study ID #: OBI-1-301a
• Status: No longer available

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Hemophilia A
• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States,