NIPH Clinical Trials Search

A CLINICAL STUDY TO EVALUATE THE EFFECTS OF NXT007 COMPARED TO EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hemophilia-A
Date of first enrollment	01/04/2026
Target sample size	360
Countries of recruitment
Study type	Interventional
Intervention(s)	NXT007:Subcutaneous injection, Protocol-specified dosage Emicizumab:Subcutaneous injection, Protocol-specified dosage

Outcome(s)

Primary Outcome

Efficacy Annualized number of treated bleeds (ABR) over the main study treatment period from the Month 2 visit until the Clinical cutoff date

Secondary Outcome

Efficacy,Safety,Phamacokinetics,Phamacodynamics,other ABR for All Bleeds Over the Main Study Treatment Period from Month 2 until the clinical cutoff date ABR for Treated Spontaneous Bleeds Over the Main Study Treatment Period from Month 2 until the clinical cutoff date ABR for Treated Joint Bleeds Over the Main Study Treatment Period from Month 2 until the clinical cutoff date ABR for Treated Target Joint Bleeds Over the Main Study Treatment Period from Month 2 until the clinical cutoff date Adjusted Mean Treatment Burden Domain Score in Comprehensive Assessment Tool of Challenges in Hemophilia (CATCH) Questionnaire - Adult Version at Month 8 Mean Treatment Burden Domain Score in CATCH Questionnaire - Adolescent Version at Month 8 Change From Baseline in Preoccupation Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions) Change From Baseline in Social Activity Impact Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions) Change From Baseline in Recreational Activity Impact Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions) Physical Impact Domain Score of the Treatment Administration Satisfaction Questionnaire (TASQ) at Specified Timepoints Incidence and Severity of Adverse Events, With Severity Determined According To National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5.0) Grading Scale Incidence and Severity of Thromboembolic Events and Thrombotic Microangiopathy Incidence and Severity of Injection-Site Reactions Incidence of Adverse Events Leading to Discontinuation of Assigned Study Treatment Incidence of Severe Hypersensitivity, Anaphylaxis, or Anaphylactoid Reactions Plasma Concentration of NXT007 Percentage of Participants With Anti-Drug Antibodies (ADAs) Against NXT007 at Baseline and During the Study Percentage of Participants With Neutralizing ADAs Against NXT007

Key inclusion & exclusion criteria

Age minimum	>= 12age old
Age maximum	Not applicable
Gender	Both
Include criteria	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
Exclude 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 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)