REGN7508
DrugAdministered per the protocol
Other names: cenvacibart
NCT Number: NCT07015905
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.
The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery.
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Multi-profile Hospital for Active Treatment Hearth and Brain EAD, Pleven, Bulgaria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Administered per the protocol
Other names: cenvacibart
Administered per the protocol
Administered per the protocol
Other names: Inhixa
Administered per the protocol
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Through day 12 visit, approximately 14 days
Time frame: Approximately day 90
Time frame: Approximately day 90
Time frame: Approximately day 90
Time frame: Approximately day 90
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)
Acronym: ROXI-APEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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