A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
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
- Hemophilia A
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Hoffmann-La Roche
- Enrolment target
- 138
- Started
- 15 May 2026
- Main results due
- 23 September 2027
- Study sites
- 32
- Registry updated
- 23 September 2026
Can you take part?
- Aged 12 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Diagnosis of severe (FVIII:C \<1 IU/dL \[International Unit per decilitre\]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A without inhibitors against FVIII * No documented inhibitor (i.e., \<0.6 BU/mL \[Bethesda unit per millilitre\]), FVIII half-life ≥6 hours, or FVIII recovery \>66% in the last 3 years prior to screening * Documented historical negative test for FVIII inhibitor (i.e., \<0.6 BU/mL) within 12 months prior to enrollment * Documentation of the details of prophylactic and episodic FVIII treatment and of the number and type of bleeding episodes for at least the last 6 months prior to screening * Agreement to adhere to the contraception requirements (for potential participants with childbearing potential) Exclusion Criteria: * Sensitivity to any of the study investigations, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study * Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for anti-retroviral therapy to treat HIV * Planned surgery (excluding minor procedures such as non-molar tooth extraction, incision and drainage) during the study * History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third- degree atrioventricular heart block) or ECG evidence or clinical history of prior myocardial infarction * Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(32)
University of Colorado Hemophilia and Thrombosis Center
Aurora, Colorado, United States
Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Recruiting
Arbesu Hematologia
Godoy Cruz, Mendoza Province, Argentina
Recruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, São Paulo, Brazil
Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, China
Suspended
Rigshospitalet-Blegdamsvej 9
Copenhaen, Denmark
Recruiting
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, Val-de-Marne, France
Recruiting
Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon
Bron, France
Recruiting
CHU de Lille - Institut Cœur Poumon
Lille, France
Recruiting
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Recruiting
Eszak-Pesti Centrumkorhaz -Honvedkorhaz
Budapest, Pest County, Hungary
Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Recruiting
Nara Medical University Hospital
Kashihara-shi, Nara, Japan
Recruiting
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Recruiting
Haemophilia Comprehensive Care Centre
Parktown, Gauteng, South Africa
Recruiting
Kyung Hee University Hospital at Gangdong
Gangdong-gu, Seoul, South Korea
Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, South Korea
Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Recruiting
Hospital Universitario La Paz - PPDS
Madrid, Spain
Recruiting
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, Spain
Recruiting
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Recruiting
Universitätsspital Zürich
Zurich, Switzerland
Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan
Recruiting
Tri-Service General Hospital
Taipei, Taiwan
Recruiting
The Royal London Hospital
London, Middlesex, United Kingdom
Recruiting
University Hospital of Wales
Cardiff, United Kingdom
Recruiting
St Thomas' Hospital
London, United Kingdom
Recruiting
Churchill Hospital
Oxford, United Kingdom
Recruiting
Showing 32 of 32 sites. 31 of the 32 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07416526. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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