Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia



Status:Active, not recruiting
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 75
Updated:12/1/2018
Start Date:June 14, 2017
End Date:April 30, 2022

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A Global Epidemiologic Study to Determine the Prevalence of Neutralizing Antibodies and Related Adaptive Immune Responses to Adeno-Associated Virus (AAV) in Adults With Hemophilia

Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe
hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia
B (coagulation factor IX [FIX] ≤2%).


Inclusion Criteria:

1. Participant is male between 18 and 75 years old at the time of screening.

2. Established severe hemophilia A (plasma Factor VIII (FVIII) activity <1%) or B (plasma
Factor IX (FIX) activity ≤2%).

3. Provision of signed informed consent form (ICF).

4. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

1. Bleeding disorder(s) other than hemophilia A or B.

2. Personal laboratory evidence of having developed inhibitors to FVIII or FIX protein at
any time (≥0.6 Bethesda Units [BU] on any single test).

3. Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy,
immunoglobulin therapy, or monoclonal antibody therapy.

4. Received systemic antiviral and/or interferon therapy within 30 days of blood draw,
with the exception of treatment for human immunodeficiency virus (HIV).

5. Currently receiving ribavirin and/or interferon based therapy for active hepatitis C
virus (HCV).

6. Received immunoglobulin therapy or plasma infusion within 120 days of the blood draw.

7. Has a known immune deficiency other than HIV.

8. Has lymphocyte or plasma cell malignancies.

9. Participant is a family member or employee of the investigator.
We found this trial at
8
sites
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Aurora, CO
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Charleston, South Carolina 29425
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Charleston, SC
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East Lansing, Michigan 48824
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East Lansing, MI
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Houston, TX
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Los Angeles, California 90007
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Los Angeles, CA
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Vienna,
Principal Investigator: Ingrid Pabinger-Fasching, MD
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Vienna,
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