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Compares treatment options for Hemophilia A
Official title A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
ClinicalTrials.gov ID: NCT07416604
What this study is testing
What is NXT007?
NXT007 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hemophilia a.
Also referred to as Zemocimig, RO7589655.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- Diagnosis of mild (FVIII:C between \>5 IU/dL and \<40 IU/dL) congenital hemophilia A with chronic FVIII inhibitors, defined as documented FVIII...
- 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...
- For potential participants taking on-demand treatments prior to study entry: agreement to move to a prophylaxis treatment with either emicizumab or...
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...
- Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for antiretroviral...
- 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...
- History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third-degree...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Seattle, Washington, United States
- Ramat Gan, Central District, Israel
- Nagoya, Aiti, Japan
- Maebashi, Gunma, Japan
- Kashihara-shi, Nara, Japan
- Suginami-Ku, Tokyo, Japan
- Madrid, Spain
- Málaga, Spain
- Valencia, Spain
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Indianapolis, Indiana, United States; Iowa City, Iowa, United States; Seattle, Washington, United States; Ramat Gan, Central District, Israel; Nagoya, Aiti, Japan and 6 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 ClinicalTrials.gov; the study team decides eligibility.