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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

Primary Purpose

Acquired Hemophilia A

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
OBI-1
Sponsored by
Baxalta now part of Shire
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Acquired Hemophilia A focused on measuring Factor VIII Inhibitory Auto-antibodies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • National Institutes of Health Warren G. Magnuson Clinical Center
  • Tufts Medical Center
  • Penn State
  • Vanderbilt Hemostasis/Hemophilia Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 21, 2013
Last Updated
May 3, 2021
Sponsor
Baxalta now part of Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01968655
Brief 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
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 Type
Expanded Access

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Hemophilia A
Keywords
Factor VIII Inhibitory Auto-antibodies

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
OBI-1
Other Intervention Name(s)
B-Domain Deleted Recombinant Porcine Factor VIII
Intervention Description
OBI-1 is a B domain deleted recombinant porcine factor VIII

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
National Institutes of Health Warren G. Magnuson Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Penn State
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Vanderbilt Hemostasis/Hemophilia Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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