What is the Purpose of this Study?
The study is focused on adults undergoing a placement of a catheter in their vein, also called a PICC (peripherally inserted central catheter) line, which is used to deliver drugs into the bloodstream, such as chemotherapy, antibiotics, and total parenteral nutrition. The purpose of the study is to evaluate the effectiveness of 2 experimental drugs, REGN9933 and REGN7508, in preventing venous thromboembolism (VTE) and other related disease after catheter placement. A VTE is a blood clot (thrombus) that has formed in a vein and can move anywhere in the body and block blood flow. A piece of the clot may break loose (embolus) and cause a life-threatening clot called a pulmonary embolism. Researchers want to learn about any side effects of the drug, how much of the drug is in the blood at different times, and whether the body makes antibodies against the drug (which could make it less effective or lead to side effects). REGN9933 and REGN7508 are antibodies (a protein produced by the body’s immune system when it detects bacteria and viruses). Factor XI is a protein that plays an important role in the formation of blood clots. REGN9933 and REGN7508 can attach to Factor XI with the aim of reducing or preventing blood clot formation. Participants will be randomly assigned to receive either REGN9933, REGN7508, or placebo (inactive substance).
Eligibility
- 1. PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
- 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
- 3. Body weight ≥45 kg and ≤130 kg during the screening period
- 4. International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
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