At a glance
ClinicalIndex Comparison Record- ✓Undergoing elective unilateral total knee arthroplasty (TKA)
- ✓Body weight ≤130 kg at screening
- ✓Judged to be in good health based on medical history, physical exam, vital signs, and ECG at screening
- ✓Good health based on laboratory safety testing during screening
- ✕History of bleeding in past 6 months requiring hospitalization or transfusion; intracranial or intraocular bleeding; excessive operative/post-operative bleeding; traumatic spinal or epidural anesthesia; or bleeding diathesis
- ✕History of thromboembolic disease or thrombophilia
- ✕Major surgery (including brain, spinal, or ocular) within approximately 6 months
- ✕Major trauma within approximately 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty
In Brief
A Phase 2 clinical trial evaluating REGN9933, Enoxaparin, and 1 other intervention for Venous Thromboembolism. Completed, enrolled 373 participants across 16 sites in 7 countries.
Detailed Summary
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 The secondary objectives of the study are: * To evaluate the bleeding risk (ie, major and clinically relevant non-major \[CRNM\] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin * To assess overall safety and tolerability of REGN9933 in participants undergoing TKA * To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin * To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin * To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration * To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways * To assess immunogenicity following a single dose of REGN9933 over time * To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA
Study Details
Timeline
Interventions
Participants will receive a single dose of REGN9933 by IV infusion
Participants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier)
Participants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier)