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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

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

Page last updated: August 23, 2015

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