Inhibitor Development in Patients With Hemophilia A Undergoing Surgery
Completed
Conditions studied: Hemophilia A
In brief
Hemophilia A is a genetic deficiency of factor VIII that causes blood to clot too slowly. The disease is classified based on how much factor VIII is in the blood. People with mild or moderate hemophilia A have low, but detectable, blood levels of factor VIII and bleed with trauma or surgery. At the time of surgery, they need to receive factor VIII replacement by infusion into the vein so that blood can clot normally and abnormal bleeding can be avoided. A complication of hemophilia A is the development of an antibody that binds factor VIII and makes the factor VIII infused for treatment not work properly. This antibody is called an inhibitor. In mild and moderate hemophilia A, inhibitors are not common, but have been reported to occur after intensive factor VIII infusions, as may occur at the time of surgery. This study is designed to observe people with mild and moderate hemophilia A who are having surgery. Information on the surgery, treatments given, bleeding, and infection will be gathered. Also, blood will be drawn to determine how the immune system is reacting to the factor VIII. No specific treatments will be given as part of this study. We will use the information to determine what influences inhibitor development. A better understanding of inhibitor development will help medical providers do things to avoid inhibitor development in this population or researchers to design new treatments.
Key facts
- Study ID
- NCT01571934
- Run by
- Emory University
- People needed
- 30
- Starts
- 2011-11-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-04-26
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Males with mild/moderate hemophilia A (fVIII activity 1-40%)
- Planned surgical intervention which is anticipated to require 5 consecutive days of fVIII replacement therapy (These can be outpatient or inpatient treatment days.)
- Weight >22.5 kg (To assure that volumes of blood to be drawn for study purposes are safe.)
You may not qualify if…
- Past history of an inhibitor (inhibitor titer >0.4 BU/ml)
- HIV infection with CD4 count <400/ul
- Currently receiving immunosuppressive medication(s)
- Unable to tolerate quantity of blood to be drawn
- Current or past diagnosis autoimmune disorder
- Current or past diagnosis of immune deficiency disorder other than HIV
Where it is running
- University of Colorado, Hemophilia and Thrombosis Center — Aurora, Colorado, United States
- Emory University Comprehensive Hemophilia Treatment Center — Atlanta, Georgia, United States
- Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- Oregon Health & Science University — Portland, Oregon, United States
- University of Pittsburgh and Hemophilia Center of Pennsylvania — Pittsburgh, Pennsylvania, United States
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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