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
Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acquired Hemophilia A
Intervention: OBI-1 (Biological)
Phase: N/A
Status: No longer available
Sponsored by: Baxalta US Inc. Official(s) and/or principal investigator(s): Heinrich Farin, MD, Study Director, Affiliation: Baxter Healthcare Corporation
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.
Clinical Details
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
Study design: N/A
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
National Institutes of Health Warren G. Magnuson Clinical Center, Bethesda, Maryland 20892, United States
Tufts Medical Center, Boston, Massachusetts 02111, United States
Penn State, Hershey, Pennsylvania 17033, United States
Vanderbilt Hemostasis/Hemophilia Clinic, Nashville, Tennessee 37232, United States
Additional Information
Last updated: June 26, 2015
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