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
- Ann Arbor, Aurora, Indianapolis, Iowa City, Miami, Minneapolis, Orange, San Antonio, Seattle, and Tampa, United StatesSee the 10 sites
- Phase
- Phase 3
Where in United States
- University of Michigan - 1500 E Medical Center DrAnn Arbor, United StatesTaking people
- University of Colorado Hemophilia and Thrombosis CenterAurora, United StatesTaking people
- Innovative Hematology, Inc.Indianapolis, United StatesTaking people
- University of Iowa Hospitals and ClinicsIowa City, United StatesTaking people
- University of Miami HospitalMiami, United StatesTaking people
- M Health Fairview - Pediatric Specialty Clinic-DiscoveryMinneapolis, United StatesTaking people
- Center for Inherited Blood DisordersOrange, United StatesTaking people
- The University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
- Washington Center for Bleeding DisordersSeattle, United StatesTaking people
- St Joseph's Children's Hospital of TampaTampa, United StatesTaking 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.