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

May 3, 2021 updated by: Baxalta now part of Shire
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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Warren G. Magnuson Clinical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Hemostasis/Hemophilia Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (ESTIMATE)

October 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBI-1-301a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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