A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)

Launched by REGENERON PHARMACEUTICALS · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two new experimental medications, REGN9933 and REGN7508, to see how well they work at preventing blood clots in adults who will have a special type of catheter placed in their veins, known as a PICC line. Blood clots can be a serious issue for patients with this type of catheter, so the researchers want to find out if these medications can help keep patients safe. They will also be looking at how safe these drugs are, what side effects they may cause, and how the body reacts to them over time.

To participate in this trial, adults aged 18 and older who are expected to have their PICC line in place for at least 14 days may be eligible, provided they meet certain health criteria. For instance, participants should have a healthy weight and blood counts, and they should not have a history of serious blood clotting issues. If you join the study, you will be monitored closely to track how the medication works for you and to ensure your safety. This trial is a valuable opportunity to help improve care for patients needing PICC lines while also contributing to medical research.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. PICC 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 ≥50 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
• • 5. Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol
• Key Exclusion Criteria:
• • 1. Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant
• • 2. History of prior venous thrombosis in the arm in which the PICC is to be placed
• • 3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
• • 4. History of known thromboembolic disease or thrombophilia
• • 5. Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol
• • 6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
• • 7. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders)
• • Note: Other protocol defined inclusion/exclusion criteria apply