Comparing NXT007 with emicizumab for people with hemophilia A
Tests NXT007 against emicizumab to prevent bleeding in people with hemophilia A.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Key facts
- Where
- Debrecen, HungarySee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 and older with hemophilia A, with or without FVIII inhibitors. It compares NXT007 with emicizumab.
- Age
- 12 years and older
- Sex
- All sexes
- Disease stage
- Severe or moderate congenital hemophilia A, with or without FVIII inhibitors. Mild congenital hemophilia A only with chronic FVIII inhibitors.
- Earlier treatment
- Details of past FVIII, bypassing agent and emicizumab treatment and bleeding episodes must be documented for at least the last 6 months. People on on-demand treatment must agree to move to prophylaxis with emicizumab or NXT007.
- Biomarker or test result
- Severe: FVIII:C <1 IU/dL. Moderate: FVIII:C between ≥1 IU/dL and ≤5 IU/dL. Mild: FVIII:C between >5 IU/dL and <40 IU/dL, with chronic FVIII inhibitors and baseline FVIII:C <5 IU/dL for ≥12 months. Documented FVIII inhibitor test results from the past 12 months are needed.
Main reasons for not taking part
- Allergy or sensitivity to the study drugs or their components
- Use of systemic immunomodulators such as interferon or rituximab, except HIV antiretroviral therapy
- Refusal of plasma-derived or blood product transfusion in an emergency
- Planned surgery during the study, other than minor procedures
- History of ventricular rhythm problems, certain heart disease, a clinically significant abnormal ECG, or prior heart attack
Read by machine on 9 November 2026.
Where in Hungary
- University of DebrecenDebrecen, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07416604EU 2025-522435-33-00
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.Read full original descriptionShow less
A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Emicizumab Prophylaxis in People With Hemophilia A
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.
Inclusion: Diagnosis of severe (FVIII:C <1 International Unit per decilitre [IU/dL]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A with or without inhibitors against FVIII; Diagnosis of mild (FVIII:C between >5 IU/dL and <40 IU/dL) congenital hemophilia A with chronic FVIII inhibitors, defined as documented FVIII inhibitor ( ≥0.6 BU/mL or ≥1.0 BU/mL only for laboratories with a historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL) and chronic reduction of endogenous baseline FVIII:C to <5 IU/dL for ≥12 months; Documented historical FVIII inhibitor assay results within the 12 months prior to enrollment; Documentation of the details of prophylactic and episodic FVIII treatment, bypassing agent (BPA) treatment, emicizumab prophylaxis treatment, and the number and type of bleeding episodes for at least the last 6 months prior to screening; For potential participants taking on-demand treatments prior to study entry: agreement to move to a prophylaxis treatment with either emicizumab or NXT007, according to assigned randomization.
Exclusion: Planned surgery (excluding minor procedures, such as non-molar tooth extraction or 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 evidence or clinical history of prior myocardial infarction; 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 antiretroviral therapy to treat HIV; 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); Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario.