A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe The… (NCT06299111) | Clinical Trial Compass
CompletedPhase 2
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)
United States, Bulgaria, Canada195 participantsStarted 2024-09-20
Plain-language summary
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
. Body weight ≥45 kg and ≤130 kg during the screening period
. 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
. Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of confirmed VTE per central reading center (CRC) review
Timeframe: Through Day 14
2
Incidence of treatment-emergent adverse event (TEAEs)
. 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
. History of prior venous thrombosis in the arm in which the PICC is to be placed
. 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
. History of known thromboembolic disease or thrombophilia
. Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol
. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
. 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) as described in the protocol