A Phase 2, Multicenter, Randomized, Open-label, Active-Control Study of REGN7508, a Factor XI Monoclonal Antibody, for the Prevention of Venous Thromboembolism in Participants Undergoing an Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)
This study, called ROXI-VTE II, is looking at a new medicine called REGN7508. This medicine aims to stop blood clots from forming in your veins after you've had a total knee replacement operation. Blood clots, also known as Venous Thromboembolism (VTE), can be serious. Researchers want to see if REGN7508 is effective at preventing these clots and if it's safe to use, compared to a commonly used medicine called Inhixa or Clexane. Patients taking part will be given either the new medicine or the standard medicine to prevent clots, and doctors will carefully check for any clots or bleeding during the first 12 days after surgery, and then monitor them for side effects over about 75 days.
At a glance
What is this study about?
When you have a big operation like a knee replacement, there's a risk of blood clots forming in your legs or lungs. These clots are called Venous Thromboembolism (VTE) and can be very serious. To prevent this, doctors usually give you medicines that thin your blood.
This study is testing a new medicine called REGN7508. It's designed to stop these blood clots from forming. Researchers want to find out if REGN7508 is better or as good as the medicines currently used, like Inhixa or Clexane, at preventing these clots after knee surgery. They also want to understand if the new medicine causes any unwanted side effects, especially bleeding, which can be a risk with blood-thinning medicines.
The study is in its second phase, meaning it has already been tested in a smaller group of people. Now, they are looking more closely at how well it works and its safety in a larger group. The main goal is to carefully count how many people get blood clots within about 12 days of their surgery. They will also keep a close eye on any bleeding and other side effects for about 75 days.
Key takeaways
- This study tests a new medicine (REGN7508) for preventing blood clots after knee replacement.
- It compares REGN7508 with existing clot-prevention medicines like Inhixa/Clexane.
- The main focus is on preventing clots and monitoring for bleeding after surgery.
- Participation involves receiving medicine and regular health checks for about 75 days.
- You could contribute to medical research on blood clot prevention.
Who may be eligible?
To be part of this study, you would need to be an adult, aged 18 or older. Both men and women can take part.
Crucially, you would need to be scheduled for a new knee replacement operation on one knee. This must be an operation that has been planned in advance, rather than an emergency.
There will be other detailed health checks to make sure the study is right for you and safe. Your doctor will discuss all the specific requirements if you are interested.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you scheduled for a planned, single knee replacement operation?
- Do you want to help test new ways to prevent blood clots?
- Are you able to attend follow-up appointments for approximately 75 days?
What does participation involve?
If you decide to take part, you would receive either the new study medicine, REGN7508, or a standard medicine like Inhixa/Clexane, to prevent blood clots after your knee replacement surgery. This would be given to you for about 12 days. Doctors would closely monitor you for any signs of blood clots or bleeding during this initial period.
You would also have several check-up visits where healthcare staff will ask about your health, take blood samples, and perform some tests to see how the medicine is affecting your body. These checks would continue for approximately 75 days after your surgery to monitor for any side effects and see how the medicine is working in your system. Throughout this time, you would be in regular contact with the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedHungary
- —UnverifiedLatvia
- —UnverifiedLithuania
Common questions
What is a 'blood clot'?
A blood clot is a thick lump of blood that can form inside your veins. It can be serious if it stops blood flow or travels to your lungs.
What is a 'knee replacement operation'?
This is a surgical procedure where parts of your damaged knee joint are replaced with artificial parts, usually to relieve pain and improve movement.
Is REGN7508 already available to patients?
No, REGN7508 is an experimental medicine being tested in this study. It's not yet available for general use.
Will I know if I'm getting the new medicine or the standard one?
Because this is an 'open-label' study, you and your doctors will know which medicine you are receiving.
How long will I be in the study overall?
You will be closely monitored for about 12 days after your surgery, and then for side effects and other checks for a total of approximately 75 days.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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