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

Completed

Conditions studied: Hemophilia A, Hemophilia B

In brief

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%).

Key facts

Study ID

NCT03185897

Run by

Baxalta now part of Shire

People needed

242

Starts

2017-06-14

Expected to finish

2021-03-17

Last updated by the study team

2021-10-25

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Participant is male between 18 and 75 years old at the time of screening.
• Established severe hemophilia A (plasma Factor VIII (FVIII) activity <1%) or B (plasma Factor IX (FIX) activity ≤2%).
• Provision of signed informed consent form (ICF).
• Participant is willing and able to comply with the requirements of the protocol.

You may not qualify if…

• Bleeding disorder(s) other than hemophilia A or B.
• Personal laboratory evidence of having developed inhibitors to FVIII or FIX protein at any time (≥0.6 Bethesda Units [BU] on any single test).
• Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy, or monoclonal antibody therapy.
• Received systemic antiviral and/or interferon therapy within 30 days of blood draw, with the exception of treatment for human immunodeficiency virus (HIV).
• Currently receiving ribavirin and/or interferon based therapy for active hepatitis C virus (HCV).
• Received immunoglobulin therapy or plasma infusion within 120 days of the blood draw.
• Has a known immune deficiency other than HIV.
• Has lymphocyte or plasma cell malignancies.
• Participant is a family member or employee of the investigator.

Where it is running

• 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

Full record on ClinicalTrials.gov

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