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A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
Sponsor: Hoffmann-La Roche
Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.
Official title: A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Factor VIII Prophylaxis in People With Hemophilia A Without Inhibitors
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2026-05-15
Completion Date
2031-09-23
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
NXT007
NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.
Human Coagulation Factor VIII
Factor VIII (FVIII) prophylaxis standard of care (SOC) will be administered at the dose and frequency as stated in the local labels and per local country practice.
Locations (32)
University of Colorado Hemophilia and Thrombosis Center
Aurora, Colorado, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Arbesu Hematologia
Godoy Cruz, Mendoza Province, Argentina
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, São Paulo, Brazil
Peking University People's Hospital
Beijing, Beijing Municipality, China
Rigshospitalet-Blegdamsvej 9
Copenhaen, Denmark
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, Val-de-Marne, France
Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon
Bron, France
CHU de Lille - Institut Cœur Poumon
Lille, France
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Eszak-Pesti Centrumkorhaz -Honvedkorhaz
Budapest, Pest County, Hungary
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Nara Medical University Hospital
Kashihara-shi, Nara, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Haemophilia Comprehensive Care Centre
Parktown, Gauteng, South Africa
Kyung Hee University Hospital at Gangdong
Gangdong-gu, Seoul, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, South Korea
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Hospital Universitario La Paz - PPDS
Madrid, Spain
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Universitätsspital Zürich
Zurich, Switzerland
Taichung Veterans General Hospital
Taichung, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
The Royal London Hospital
London, Middlesex, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
St Thomas' Hospital
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom