Actively Recruiting
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Led by Hoffmann-La Roche · Updated on 2026-05-07
360
Participants Needed
6
Research Sites
300 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
C
Chugai Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of severe or moderate congenital hemophilia A with or without factor VIII inhibitors
- Diagnosis of mild congenital hemophilia A with chronic factor VIII inhibitors lasting at least 12 months
- Documented factor VIII inhibitor test results within 12 months before enrollment
- Recorded details of prior prophylactic and episodic treatments and bleeding episodes for at least 6 months before screening
- Agreement to switch to prophylaxis treatment with either emicizumab or NXT007 if previously on-demand treatment
You will not qualify if you...
- Allergy or sensitivity to study procedures, drugs, or components that contraindicate study participation
- Use or planned use of systemic immunomodulators during the study (except HIV antiretroviral therapy)
- Refusal to accept plasma-derived or blood transfusion support in emergencies
- Planned surgery during the study other than minor procedures
- History of ventricular dysrhythmias or risk factors like severe heart dysfunction or coronary heart disease
- History or presence of clinically significant abnormal ECG or prior heart attack
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Center for Inherited Blood Disorders
Orange, California, United States, 92868
Actively Recruiting
2
Innovative Hematology, Inc.
Indianapolis, Indiana, United States, 46260
Actively Recruiting
3
Washington Center for Bleeding Disorders
Seattle, Washington, United States, 98101-3932
Actively Recruiting
4
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Actively Recruiting
5
Nara Medical University Hospital
Kashihara-shi, Nara, Japan, 634-8522
Actively Recruiting
6
Ogikubo Hospital
Suginami-Ku, Tokyo, Japan, 167-0035
Actively Recruiting
Research Team
R
Reference Study ID Number: BO45887 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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