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

未提供0 个研究点目标入组 360 人开始时间: 待定

适应症

试验速览

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•Diagnosis of severe (FVIII:C < 1 IU/dL) or moderate (FVIII:C between >= 1 IU/dL and <= 5 IU/dL) congenital HA 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, 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 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
•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)

发起方

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