67
Participants
Start Date
June 27, 2018
Primary Completion Date
September 22, 2021
Study Completion Date
March 19, 2025
AAV5-hFIXco-Padua
Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
Factor IX (FIX)
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
Cliniques Universitaires Saint-Luc, Brussels
Righospitalet, Copenhagen
University Hospital Leuven, Leuven
Vivantes Klinikum im Friedrichshain, Berlin
Hemophilia Center of Western New York, Buffalo
Children's National Medical Center Hematology and Oncology, Washington D.C.
University of North Carolina, Chapel Hill, Chapel Hill
University of South Florida, Tampa
Vanderbilt University Medical Center, Nashville
University of Tennessee Health Science Center, Memphis
University of Michigan, Ann Arbor
Klinikum der Johann Wolfgang Goethe Universitat, Frankfurt am Main
Arkansas Children's Hospital, Little Rock
University of Texas Health Science Center & Medical School, Houston
University of Colorado Denver, Aurora
University of Utah, Salt Lake City
Phoenix Children's Hospital, Phoenix
Los Angeles Orthopedic Hospital, Los Angeles
Children's Hospital of Los Angeles, Los Angeles
University of California, San Diego, San Diego
University of California, Davis, Sacramento
Oregon Health & Science University, Portland
Washington Institute for Coagulation, Seattle
Bloodworks Northwest, Seattle
National Coagulation Centre, St James's Hospital, Dublin
Amsterdam UMC - Locatie AMC, Amsterdam
Universitair Medisch Centrum Groningen, Groningen
Erasmus MC, Rotterdam
UMC Utrecht, Van Creveldkliniek, Utrecht
Center for Thrombosis and Hemostasis Skåne University Hospital Malmö, Malmo
The Cambridge Haemophilia and Thrombophilia Centre Camridge University Hospitals NHS Foundation Trust - Box 217 Addenbrooke's Hospital, Cambridge
The Royal London Hospital (Barts Health NHS Trust), London
University Hospital Southampton NHS Foundation Trust, Southampton
Lead Sponsor
CSL Behring
INDUSTRY