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NXT007 vs. Emicizumab for Hemophilia A

This study is comparing a new treatment called NXT007 to an existing treatment, emicizumab, for people with hemophilia A. Researchers want to see how well NXT007 works to prevent bleeding episodes and how safe it is. You might be able to join if you are 12 years or older and have severe or moderate hemophilia A, with or without inhibitors (antibodies that can make treatment less effective). People with mild hemophilia A and inhibitors may also be eligible. The main goal is to measure the Annualized Bleed Rate (ABR), which is the number of treated bleeds per year, over at least 7 months of treatment. The study is currently recruiting 360 participants, but its overall status is unclear.

Study design
This is an interventional study comparing two treatments. It plans to enroll 360 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures treated bleeds from Month 2 until the clinical cutoff date, which is at least 7 months of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07416604

A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A

Recruiting
PHASE3Ages 12+InterventionalTreatment
Hoffmann-La Roche
~360 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:NXT007Emicizumab

At a glance

Recruiting sites
30 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period
Measured over From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

Conditions

Hemophilia A

Explore related trials

Hemophilia AFVIII inhibitor

Where it's being run

30 sites across 24 states
Spain6
Lombardy2
California1
Colorado1
Florida1
Indiana1
Iowa1
Washington1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: BO45887 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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
Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario
Planned surgery (excluding minor procedures, such as non-molar tooth extraction or incision and drainage) during the study
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)
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

What this trial measures

  • Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment PeriodFrom Month 2 until the clinical cutoff date (at least 7 months of study treatment)