Last updated 6 days ago
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
360 patients around the world
Available in Argentina, Brazil, United States
Hoffmann-La Roche
3Research sites
360Patients around the world
This study is for people with
Hemophilia
Hemophilia a
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Arbesú Hematología
Recruiting
Instituto de Hematología y Medicina Clínica Dr. Rubén Dávoli
Recruiting
Hospital das Clínicas de Ribeirão Preto
Recruiting
StudyZEBRHA 2
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Hemophilia a
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07416604
