Actively Recruiting
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
Led by Hoffmann-La Roche · Updated on 2026-05-07
126
Participants Needed
2
Research Sites
280 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 Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without inhibitors. The study will include people aged ≥12 years old with severe or moderate congenital hemophilia A without inhibitors on previous FVIII prophylaxis treatment.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of severe (FVIII:C <1 IU/dL) or moderate (FVIII:C between 1 IU/dL and 5 IU/dL) congenital hemophilia A without inhibitors
- No documented inhibitor (<0.6 BU/mL), FVIII half-life 6 hours, or FVIII recovery >66% in last 3 years prior to screening
- Documented negative FVIII inhibitor test (<0.6 BU/mL) within 12 months before enrollment
- Records of prophylactic and episodic FVIII treatment and bleeding episodes for at least 6 months before screening
- Agreement to follow contraception requirements if of childbearing potential
You will not qualify if you...
- Allergy or sensitivity to study drugs, devices, or components that contraindicate study participation
- Use of systemic immunomodulators (e.g., interferon or rituximab) at enrollment or planned during study, except HIV anti-retroviral therapy
- Planned surgery during study, excluding minor procedures like simple tooth extraction or incision and drainage
- History or presence of clinically significant abnormal ECG (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or prior myocardial infarction
- Refusal to accept plasma-derived or blood product transfusions in emergencies
- History or risk factors for ventricular dysrhythmias such as structural heart disease or coronary heart disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Nara Medical University Hospital
Kashihara-shi, Nara, Japan, 634-8522
Actively Recruiting
2
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-0023
Actively Recruiting
Research Team
R
Reference Study ID Number: WO45886 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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