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A trial to learn how well REGN9933 works for preventing blood clots after knee replacement surgery in adult participants
EU CTIS ID: 2022-501470-18-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of REGN9933 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
- 1. Undergoing elective unilateral TKA
- 2. Has a body weight ≤130 kg at screening visit
- 3. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and Electrocardiograms (ECG) performed at screening and/or prior to administration of initial dose of study drug
- 4. Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol
- Other protocol-defined inclusion criteria apply
You likely can't join if
- 1. History of bleeding in the past 6 months 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.
- 2. History of thromboembolic disease or thrombophilia.
- 3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months.
- 4. History of major trauma within approximately the past 6 months.
- 5. Hospitalized (>24 hours) for any reason within 30 days of the screening visit.
- 6. Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol.
See the full eligibility criteria
- 1. Undergoing elective unilateral TKA
- 2. Has a body weight ≤130 kg at screening visit
- 3. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and Electrocardiograms (ECG) performed at screening and/or prior to administration of initial dose of study drug
- 4. Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol
- Other protocol-defined inclusion criteria apply
- 1. History of bleeding in the past 6 months 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.
- 2. History of thromboembolic disease or thrombophilia.
- 3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months.
- 4. History of major trauma within approximately the past 6 months.
- 5. Hospitalized (>24 hours) for any reason within 30 days of the screening visit.
- 6. Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol.
- Other protocol-defined exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. Enter your location above to see the nearest site and check your eligibility.
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.