Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism after Elective, Unilateral, Total Knee Arthroplasty

This study is a medical research project looking at how well a new medicine, REGN9933, works to stop blood clots forming after total knee replacement surgery. Blood clots, also known as Venous Thromboembolism (VTE), can be a serious complication after surgery, so doctors are always looking for effective ways to prevent them. In this study, REGN9933 will be compared to standard medicines already used for preventing clots, such as Eliquis and Clexane/Inhixa. The main goal is to see how many people in each group get a blood clot within about 12 days after their surgery. We also want to understand if the new medicine causes any side effects, similar to how all new medicines are assessed before they are widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

408

Start

06 Apr 2023

Thromboembolic disease

What is this study about?

This study is designed to answer an important question: can a new medicine called REGN9933 help to prevent blood clots after knee replacement surgery? When you have a major operation like a knee replacement, there's a higher chance of developing blood clots in your veins, particularly in your legs. These clots can sometimes be serious if they travel to your lungs. Doctors call these blood clots Venous Thromboembolism, or VTE for short.

Currently, there are medicines like Eliquis (apixaban) and Inhixa/Clexane (enoxaparin) that are commonly used to prevent these clots. This study is testing REGN9933, which is a different type of medicine, to see if it can do an even better job or has different effects. By comparing REGN9933 to the standard treatments, researchers hope to find out if it's a safe and effective new option for patients.

The main thing researchers will be looking at is how many people get a blood clot within about 12 days after their surgery. They will also be carefully monitoring for any side effects, particularly any bleeding, as blood-thinning medicines can sometimes increase the risk of bleeding. This is a "Phase 2" study, which means it's an early stage of testing to see if the medicine works and is safe enough to be studied in a larger number of people later on.

Key takeaways

This study tests a new medicine (REGN9933) to prevent blood clots after knee surgery.
It compares REGN9933 to standard medicines like Eliquis and Clexane/Inhixa.
The main goal is to see how many people get blood clots and if there are side effects.
Participation involves taking medication, follow-up visits, and blood tests for about 75 days.
It's a 'Phase 2' study, meaning it's an early step in testing the new medicine's safety and effectiveness.
You have the right to leave the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to be scheduled for a specific type of surgery: an elective, total knee replacement on only one knee. "Elective" means it's a planned surgery, not an emergency.

There will be other health requirements and conditions that would mean you could or couldn't join the study, but these would be discussed in detail by the research team if you show an interest.

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 (elective) total knee replacement on only one knee?
Are you generally in good health other than your knee condition?
Are you comfortable potentially receiving a new investigational medicine?
Are you willing and able to attend all study visits and appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new medicine (REGN9933) or one of the standard clot-preventing medicines (Eliquis or Inhixa/Clexane). This is done by chance, like flipping a coin, so neither you nor the doctors can choose which medicine you get.

The main part of the study involves taking the assigned medicine after your knee replacement surgery. You would have regular check-ups, probably starting from your surgery day and continuing for about 12 days to monitor for blood clots and any side effects. There would also be longer-term follow-up visits or calls, likely extending for about 75 days in total, to track your progress and check on the overall safety of the medicine. During these visits, there might be blood tests to see how the medicine is working in your body and to check for any reactions. You might also have scans or other tests to look for blood clots.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical attention and access to a new treatment that could be more effective. However, there's always a risk that the new medicine might not work as well as expected, or it could have side effects. Blood-thinning medicines, including those used in this study, carry a risk of bleeding. The research team will carefully explain all known risks and potential side effects before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Lithuania
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Unverified
Latvia
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Unverified
Poland
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Unverified
Hungary
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Unverified
Bulgaria
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Unverified
Belgium

Common questions

What is a 'blood clot' and why is it important?

A blood clot is a clump of blood that has changed from liquid to a gel-like or semi-solid state. If a clot forms in your veins, particularly after surgery, it can block blood flow. This is important because it can cause pain and swelling, and in serious cases, it can travel to your lungs and cause life-threatening problems.

What is 'randomised' in a study?

'Randomised' means that which treatment you receive is decided purely by chance, like drawing numbers from a hat. This helps to make sure the study results are fair and unbiased, as it prevents doctors or patients from trying to choose a particular treatment.

What does 'Phase 2' mean for this study?

Phase 2 means this is an earlier stage of testing a new medicine. Researchers are trying to find out if the medicine works and if it's safe enough to be given to more people in later, bigger studies. It helps to decide the right dose and how often to take it.

Will I know which medicine I am taking?

This study is "open-label," which means both you and your study doctors will know which treatment you are receiving. This is different from some studies where treatments are 'blinded'.

What is an 'adverse event'?

An 'adverse event' is any unexpected or unwanted medical problem that happens while someone is taking part in a study. It doesn't necessarily mean it was caused by the medicine, but researchers track everything carefully to understand safety.