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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

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ClinicalTrials.gov Identifier: NCT01968655
Expanded Access Status : No longer available
First Posted : October 24, 2013
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Study Description
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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.

Condition or disease Intervention/treatment
Acquired Hemophilia A Biological: OBI-1

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Interventions
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Intervention Details:
  • Biological: OBI-1
    OBI-1 is a B domain deleted recombinant porcine factor VIII
    Other Name: B-Domain Deleted Recombinant Porcine Factor VIII
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968655


Locations
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United States, Maryland
National Institutes of Health Warren G. Magnuson Clinical Center
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Pennsylvania
Penn State
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Vanderbilt Hemostasis/Hemophilia Clinic
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01968655    
Other Study ID Numbers: OBI-1-301a
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Keywords provided by Takeda ( Baxalta now part of Shire ):
Factor VIII Inhibitory Auto-antibodies
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
 Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants