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A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People with Hemophilia A
EU CTIS ID: 2025-522435-33-00
What this study is testing
To evaluate the efficacy of NXT007 prophylaxis compared with emicizumab prophylaxis based on the non-inferiority assessment of treated bleeds
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of severe (factor VIII (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
- Documented historical FVIII inhibitor assay results within the 12 months prior to enrollment
- Documentation of the details of prophylactic and episodic FVIII treatment, by passing 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
- Agreement to adhere to the contraception requirements
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United Kingdom
- New Zealand
- Argentina
- China
- Taiwan
- South Africa
- Israel
- Canada
- Australia
- Korea, Republic of
- Mexico
- Switzerland
- United States
- Japan
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United Kingdom; New Zealand; Argentina; China; Taiwan and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.