What is the purpose of the ROXI-CATH clinical research study?

Catheters are used to deliver medications into your bloodstream, such as chemotherapy, antibiotics, total parenteral nutrition (TPN), and/or for other indications. After catheter placement in the vein, there is a risk of developing venous thromboembolism (VTE) or other related diseases, where a blood clot can form in the vein and block blood flow. The blood clot can travel to other parts of your body and cause a life-threatening condition or disability.

Currently, we are working on developing potential treatments that may prevent VTE. ROXI-CATH is a clinical research study that aims to see how safe and effective two study treatments [(REGN9933 and REGN7508)] are when compared to a placebo in preventing VTE in adults who have to undergo placement of a venous catheter. A placebo looks like a treatment but does not contain any real medicine.

What are the study treatments?

Study treatments [(REGN9933 and REGN7508)]:

These treatments are two different monoclonal antibodies. Monoclonal antibodies are proteins that are produced by the body to help fight against infections. Scientists can now make antibodies in the laboratory and produce them for the treatment of different diseases.

Placebo:

A placebo looks like a treatment but does not contain any real medicine. Researchers can tell whether an investigational treatment is effective by understanding if it works better than a placebo.

Once the study doctor confirms that you qualify, you will be randomly assigned to 1 of 3 treatment groups. One group will receive a single dose of one study treatment, another group will receive a single dose of the other study treatment, and the third group will receive a single dose of a placebo. You will have a 1 in 3 chance (33% chance) of receiving any one of these. A catheter (thin tube) will be inserted into your arm, and the investigational treatment or placebo will be administered through an intravenous (IV) infusion via the catheter.

What can I expect if I participate?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your role and responsibilities if you join the ROXI-CATH study. You may leave the study at any time without it affecting your regular health care.

If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures. Your participation may last up to 130 days, including a 30-day screening period before insertion of the venous catheter. There will be 7 study visits, and the last visit will be conducted over the phone.

There will be no cost to you for the study treatments, visits, tests, or supplies that are required for the study.  Some of the medical care that you will be given during this study is the usual care a doctor would recommend for your condition even if you were not in the study. You or your health insurance will have to pay for this usual medical care. You or your health insurance will also have to pay for medications, tests, and supplies that are not required as part of the study. The study team will discuss all of this with you.

How can I take part?

If you wish to take part in ROXI-CATH, you can fill in a short pre-screening questionnaire to see if you may be eligible.

What else should I know?

As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatment may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.

There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.

Find a study site near you

To find out more about ROXI-CATH, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.