Venous Thromboembolism Clinical Trial
Official title:
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
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05347550 -
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
|
N/A | |
| Enrolling by invitation |
NCT05794165 -
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
|
Phase 2 | |
| Completed |
NCT02379806 -
The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study
|
Phase 3 | |
| Recruiting |
NCT03691753 -
Safety and Efficacy Study of Fitaya Vena Cava Filter
|
N/A | |
| Completed |
NCT02197416 -
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
|
Phase 3 | |
| Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
| Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
| Completed |
NCT01895777 -
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
|
Phase 3 | |
| Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
| Completed |
NCT04736719 -
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT04736420 -
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT04735523 -
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
| Completed |
NCT02829957 -
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
|
Phase 2/Phase 3 | |
| Completed |
NCT02912234 -
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
|
Phase 1 | |
| Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
| Completed |
NCT02661568 -
Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)
|
N/A | |
| Completed |
NCT02223260 -
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
|
Phase 2 | |
| Completed |
NCT01431456 -
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
|
Phase 3 | |
| Completed |
NCT01976988 -
Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery
|
Phase 3 |