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

Recruiting now · Phase 3

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT07416604

Run by

Hoffmann-La Roche

People needed

360

Starts

2026-04-27

Expected to finish

2032-01-29

Last updated by the study team

2026-08-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Inherited Blood Disorders — Orange, California, United States (enrolling)
• University of Colorado Hemophilia and Thrombosis Center — Aurora, Colorado, United States (enrolling)
• St Joseph's Children's Hospital of Tampa — Tampa, Florida, United States (enrolling)
• Innovative Hematology, Inc. — Indianapolis, Indiana, United States (enrolling)
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States (enrolling)
• Washington Center for Bleeding Disorders — Seattle, Washington, United States (enrolling)
• UZ Leuven — Leuven, Antwerp, Belgium (enrolling)
• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (enrolling)
• Hospices Civils de Lyon — Bron, France (enrolling)
• Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany (enrolling)
• Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus — Debrecen, Pest County, Hungary (enrolling)
• The Chaim Sheba Medical Center - PPDS — Ramat Gan, Central District, Israel (enrolling)
• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Lombardy, Italy (enrolling)
• IRCCS Istituto Clinico Humanitas — Rozzano, Lombardy, Italy (enrolling)
• Azienda Ospedaliera Universitaria Careggi — Florence, Tuscany, Italy (enrolling)
• Nagoya University Hospital — Nagoya, Aiti, Japan (enrolling)
• Gunma University Hospital — Maebashi, Gunma, Japan (enrolling)
• Nara Medical University Hospital — Kashihara-shi, Nara, Japan (enrolling)
• Ogikubo Hospital — Suginami-Ku, Tokyo, Japan (enrolling)
• Universitair Medisch Centrum Utrecht Cancer Center - PPDS — Utrecht, Netherlands (enrolling)
• Auckland City Hospital — Auckland, New Zealand (enrolling)
• Kyungpook National University Hospital — Daegu, South Korea (enrolling)
• Hospital Universitario Vall d'Hebron - PPDS — Barcelona, Spain (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitario La Paz - PPDS — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.