We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968655
First Posted: October 24, 2013
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )
  Purpose
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 Intervention
Acquired Hemophilia A Biological: OBI-1

Study Type: Expanded Access     What is Expanded Access?
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 NLM:


Further study details as provided by Shire ( Baxalta now part of Shire ):

Intervention Details:
    Biological: OBI-1
    Other Name: B-Domain Deleted Recombinant Porcine Factor VIII
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Study Director: Heinrich Farin, MD Baxter Healthcare Corporation
  More Information

Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01968655     History of Changes
Other Study ID Numbers: OBI-1-301a
First Submitted: October 21, 2013
First Posted: October 24, 2013
Last Update Posted: October 23, 2017
Last Verified: October 2013

Keywords provided by Shire ( Baxalta now part of Shire ):
Factor VIII Inhibitory Auto-antibodies

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Antibodies
Immunoglobulins
Autoantibodies
Factor VIII
Immunologic Factors
Physiological Effects of Drugs
Coagulants