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A trial to learn how well REGN7508 works for preventing blood clots after a knee replacement in adult participants
EU CTIS ID: 2023-508602-14-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of REGN7508 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Undergoing a primary elective unilateral TKA
- Has a body weight ≤130 kg at screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECG's) performed at screening and/or prior to administration of initial dose of study drug as described in the protocol
- Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol
You likely can't join if
- History of bleeding in the past 6 months prior to dosing requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis
- History of thromboembolic disease or thrombophilia
- History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months
- History of major trauma within approximately the past 6 months prior to dosing
- Hospitalized (>24 hours) for any reason within 30 days of the screening visit
- Has an estimated GFR of <45 mL/min/1.73m2 at the screening visit using one of the following formulas: the Modification of Diet in Renal Disease (MDRD) equation, the Chronic Kidney Disease Epidemiology Collaboration equation, or equivalent equation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.