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Hemophilia B

HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
NCT03569891 | PHASE 3 | INTERVENTIONAL

This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10\^13 gc/kg.

Trial Information
33 Sites
67 Participants
Recruiting
18 Years

If interested, contact clinicaltrials@cslbehring.com for more information

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Phoenix Children's Hospital
Phoenix,Arizona,United States,85016
Arkansas Children's Hospital
Little Rock,Arkansas,United States,72202
Los Angeles Orthopedic Hospital
Los Angeles,California,United States,90007
Children's Hospital of Los Angeles
Los Angeles,California,United States,90027
University of California, Davis
Sacramento,California,United States,95817
University of California, San Diego
San Diego,California,United States,92161
University of Colorado Denver
Aurora,Colorado,United States,80045
Children's National Medical Center Hematology and Oncology
Washington,District of Columbia,United States,20010
University of South Florida
Tampa,Florida,United States,33612
University of Michigan
Ann Arbor,Michigan,United States,48109
Hemophilia Center of Western New York
Buffalo,New York,United States,14209
University of North Carolina, Chapel Hill
Chapel Hill,North Carolina,United States,27599
Oregon Health & Science University
Portland,Oregon,United States,97239
University of Tennessee Health Science Center
Memphis,Tennessee,United States,38163
Vanderbilt University Medical Center
Nashville,Tennessee,United States,37232
University of Texas Health Science Center & Medical School
Houston,Texas,United States,77030
University of Utah
Salt Lake City,Utah,United States,84108
Washington Institute for Coagulation
Seattle,Washington,United States,98101
Bloodworks Northwest
Seattle,Washington,United States,98104
Cliniques Universitaires SaintLuc
Bruxelles,Belgium,1200
University Hospital Leuven
Leuven,Belgium,3000
Righospitalet
Copenhagen,Denmark,2100
Vivantes Klinikum im Friedrichshain
Berlin,Germany,10249
Klinikum der Johann Wolfgang Goethe Universitat
Frankfurt am main,Germany,60590
National Coagulation Centre, St James's Hospital
Dublin,Ireland,D08A978
Amsterdam UMC Locatie AMC
Amsterdam,Netherlands,1105AZ
Universitair Medisch Centrum Groningen
Groningen,Netherlands,9713GZ
Erasmus MC
Rotterdam,Netherlands,3015CE
UMC Utrecht, Van Creveldkliniek
Utrecht,Netherlands,3508GA
Center for Thrombosis and Hemostasis Skne University Hospital Malm
Malmö,Sweden,SE-20502
The Cambridge Haemophilia and Thrombophilia Centre Camridge University Hospitals NHS Foundation Trust Box Addenbrooke's Hospital
Cambridge,United Kingdom,CB20QQ
The Royal London Hospital (Barts Health NHS Trust)
London,United Kingdom,E12ES
University Hospital Southampton NHS Foundation Trust
Southampton,United Kingdom,SO166YD

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov