A Master Protocol for a Phase 2 Randomized, Double-blind, Placebo-controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies against Factor XI for Prevention of Venous Thromboembolism in Patients with a Peripherally Inserted Central Catheter (ROXI-CATH).
This study is called ROXI-CATH and it's looking into new medicines, REGN9933 and REGN7508, to prevent blood clots. These clots are a common problem for people who have a special type of drip called a Peripherally Inserted Central Catheter (PICC line). Researchers want to find out if these new medicines are safe and effective in stopping these clots from forming. Part of the study will involve giving some participants a 'dummy' medicine (placebo) to compare with the real medicines. This will help doctors understand how well the new treatments work. It's an important step in finding better ways to keep patients with PICC lines healthy.
At a glance
What is this study about?
This study, called ROXI-CATH, is looking at new ways to prevent a problem called venous thromboembolism (VTE). This is when blood clots form, usually in the leg, and can sometimes travel to other parts of the body, like the lungs. For people who have a special type of drip called a Peripherally Inserted Central Catheter (PICC line) – which is a thin tube put into a vein, often in the arm, to give medicines over a long time – these blood clots can be a particular concern. We want to find out if two new medicines, REGN9933 and REGN7508, can help prevent these clots.
To do this, we are conducting a 'Phase 2' study. This means we're still in the early stages of testing, trying to understand if the medicines are safe and if they show promise in stopping clots. Some people in the study will receive one of the new medicines, while others will receive a 'placebo' which looks just like the real medicine but contains no active ingredients. This helps us fairly compare the effects of the new medicines. Both you and your doctor won't know if you're getting the active medicine or the placebo, which helps make the study results more reliable.
The main things we'll be checking are how many people get a confirmed blood clot and any side effects the medicines might cause. We'll also look at things like major bleeding and how the medicines change certain blood tests. This information is really important to see if these new treatments could be a good option for preventing blood clots in people with PICC lines in the future.
Key takeaways
- This study evaluates new medicines to prevent blood clots in people with PICC lines.
- It's a 'Phase 2' study, focusing on safety and initial effectiveness.
- You might receive an active medicine or a placebo (dummy medicine).
- Doctors will carefully monitor you for clots and any side effects.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning people of any age above 18 can potentially join.
Both men and women are welcome to take part in this research. The study needs a wide range of people to understand how the new medicines work in different individuals.
Further checks will be done by the study team to make sure it's safe and appropriate for you to participate, based on your specific health situation.
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?
- Do you currently have a PICC line?
- Are you able to attend regular clinic appointments?
- Are you healthy enough to participate in a clinical study?
What does participation involve?
If you decide to join this study, you would first have a screening visit to check if you meet all the health requirements. If you do, you would then be randomly assigned to receive one of the new study medicines or a matching dummy medicine (placebo). Neither you nor the study team would know which one you are receiving. You would receive treatment over a set period, which the study team will explain in detail.
Throughout the study, you would attend regular visits to the clinic. At these visits, doctors and nurses will monitor your health, perform physical exams, take blood samples, and ask about any side effects you might be experiencing. We will also carefully check for any signs of blood clots. There will be a follow-up period after your treatment ends to ensure your safety and collect final information about your health. The total duration of your participation, including screening, treatment, and follow-up, will be explained fully by the study team.
Potential risks and benefits
Locations (3)
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Common questions
What is a PICC line?
A PICC line is a thin tube put into a vein, usually in your arm, to give you medicines or fluids over a long time.
What are blood clots?
Blood clots are lumps that form in your blood, and they can sometimes block blood flow. They can be serious if they travel to your lungs.
What does 'double-blind' mean?
It means that neither you nor your doctor will know if you're getting the active study medicine or the dummy medicine (placebo).
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real treatment but doesn't contain any active ingredients. It helps us compare the new medicine's effects.
How long will the study last for me?
The study team will give you a clear timeline, including how long you'll receive treatment and how many follow-up visits you'll need.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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