Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia
NCT ID: NCT03185897
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
242 participants
OBSERVATIONAL
2017-06-14
2021-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hemophilia A
Participants with hemophilia A
Non-treatment, seroprevalence
Non-treatment study examining the prevalence of preexisting immunity to adeno-associated virus (AAV)
Hemophilia B
Participants with hemophilia B
Non-treatment, seroprevalence
Non-treatment study examining the prevalence of preexisting immunity to adeno-associated virus (AAV)
Interventions
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Non-treatment, seroprevalence
Non-treatment study examining the prevalence of preexisting immunity to adeno-associated virus (AAV)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
MALE
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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Orthopaedic Hemophilia Treatment Center
Los Angeles, California, United States
University of Colorado Hemophilia & Thrombosis Center
Aurora, Colorado, United States
Michigan State University
East Lansing, Michigan, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Gulf States Hemophilia and Thrombophilia Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
AKH - Medizinische Universität Wien
Vienna, , Austria
Hôpital Morvan
Brest, , France
Groupement Hospitalier Est- Hôpital Louis Pradel
Bron, , France
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hopital Jeanne de Flandre - CHU Lille
Lille, , France
Hôpital de la Timone
Marseille, , France
CHU de Nantes Site Hotel Dieu
Nantes, , France
Vivantes Klinikum im Friedrichshain
Berlin, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Presidio Ospedaliero di Castelfranco Veneto
Castelfranco Veneto, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Bortolo di Vicenza
Vicenza, , Italy
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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201601
Identifier Type: -
Identifier Source: org_study_id