Status:
RECRUITING
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Chugai Pharmaceutical
Conditions:
Hemophilia A
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
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
Key Trial Info
Start Date :
April 30 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2032
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07416604
Start Date
April 30 2026
End Date
January 29 2032
Last Update
April 7 2026
Active Locations (3)
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1
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
2
Nara Medical University Hospital
Kashihara-shi, Nara, Japan, 634-8522
3
Ogikubo Hospital
Suginami-Ku, Tokyo, Japan, 167-0035