REGN7508
DrugAdministered by single intravenous (IV) dose
NCT Number: NCT06454630
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 (TKR) 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 unilateral 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 drug less effective or could lead to side effects)
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Notify Me50 year and older
All sexes
Interventional
Phase 2
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 by single intravenous (IV) dose
Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier)
Other names: Inhixa
Time frame: Through day 12
Composite endpoint that includes asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out.
Time frame: Through day 12
International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol
Time frame: Through day 75
A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time frame: Through day 12
Major VTE is a composite endpoint that includes: proximal DVT; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal PE including unexplained death for which PE cannot be ruled out.
Time frame: Through day 12
DVT measured by venography of the operated leg
Time frame: Days 1, 5, 10, 30 and 75
Time frame: Days 1, 5, 10, 30, 75
aPTT was used to measure the anticipated anticoagulant effect of REGN7508. Fold change is based on the follow-up value/baseline value within an arm.
Time frame: Days 1, 5, 10, 30, 75
PT is a measure of extrinsic and/or common pathway function. Fold change is based on the follow-up value/baseline value within an arm.
Time frame: Through end of study; approximately Day 75
Immunogenicity characterized by anti-drug antibody (ADA) status
Time frame: Through end of study; approximately Day 75
Immunogenicity characterized per by ADA status
Regeneron Pharmaceuticals
Industry
A Phase 2, Multicenter, Randomized, Open-Label, Active Control Study of REGN7508, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)
Acronym: ROXI-VTE II
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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