Back to Trials
NCT07416604PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

4/27/2026

Completion Date

1/29/2032

Summary

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.

Eligibility Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * 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 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 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

Interventions

COMBINATION_PRODUCT

NXT007

DRUG

Emicizumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Hemophilia A

Locations

Center for Inherited Blood Disorders

Orange, California 92868

United States

Innovative Hematology, Inc.

Indianapolis, Indiana 46260

United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa 52242-1009

United States

Washington Center for Bleeding Disorders

Seattle, Washington 98101-3932

United States

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Central District 5262100

Israel

Nagoya University Hospital

Nagoya, Aiti 466-8560

Japan

Gunma University Hospital

Maebashi, Gunma 371-8511

Japan

Nara Medical University Hospital

Kashihara-shi, Nara 634-8522

Japan

Ogikubo Hospital

Suginami-Ku, Tokyo 167-0035

Japan

Hospital Universitario La Paz - PPDS

Madrid, 28046

Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, 29010

Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026

Spain