Hemophilia A study: NXT007 vs Emicizumab
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?
This is an investigational injectable medicine being studied as a potential treatment for hemophilia A.
Also referred to as Zemocimig, RO7589655, RG6512.
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
- This study aims to find out if NXT007 is as effective and safe as Emicizumab for preventing bleeding episodes. It also looks at how the body processes the drug.
- Who it's for
- The study is looking for people age 12 and older who have moderate or severe Hemophilia A, or any level of Hemophilia A if they have antibodies that block their clotting factor.
- What's involved
- Participants will receive either NXT007 or Emicizumab to prevent bleeds. They will undergo regular medical tests and blood draws to check how the drug is working and if it is safe.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- 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 is enrolling
- Orange, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Godoy Cruz, Mendoza Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Camperdown, New South Wales, Australia
- Melbourne, Victoria, Australia
- Parkville, Victoria, Australia
- Leuven, Antwerp, Belgium
- Brussels, Belgium
- Ribeirão Preto, São Paulo, Brazil
- São Paulo, Brazil
- London, Ontario, Canada
+ 41 more site(s).
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, but 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?
This study is enrolling now at Orange, California, United States; Aurora, Colorado, United States; Miami, Florida, United States; Tampa, Florida, United States; Indianapolis, Indiana, United States; Iowa City, Iowa, United States and 55 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.