A Phase 3 interventional study of REGN7508 and Apixaban in Venous Thromboembolism (VTE), sponsored by Regeneron Pharmaceuticals. Recruiting at 47 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
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:
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: REGN7508
Drug: REGN7508 · Drug: Placebo
Drug: Apixaban · Drug: Placebo
Drug: Enoxaparin · Drug: Placebo
Administered per the protocol
Also known as: cenvacibart
Administered per the protocol
Administered per the protocol
Also known as: Inhixa
Administered per the protocol
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]
Time frame: Through day 12 visit, approximately 14 days
Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)
Time frame: Through day 12 visit, approximately 14 days
Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)
Time frame: Through day 12 visit, approximately 14 days
Incidence of confirmed Pulmonary Embolism (PE)
Time frame: Through day 12 visit, approximately 14 days
Incidence of VTE-related death
Time frame: Through day 12 visit, approximately 14 days
Time-to-first event of confirmed symptomatic DVT
Time frame: Through day 12 visit, approximately 14 days
Time-to-first event of confirmed PE
Time frame: Through day 12 visit, approximately 14 days
Time to VTE-related death
Time frame: Through day 12 visit, approximately 14 days
Incidence of the composite endpoint of major and Clinically Relevant Non-Major (CRNM) bleeding
Time frame: Through day 12 visit, approximately 14 days
Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)
Time frame: Through day 12 visit, approximately 14 days
Incidence of minor bleeding
Time frame: Through day 12 visit, approximately 14 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Approximately day 90
Occurrence of Anti-Drug Antibodies (ADA) to REGN7508
Time frame: Approximately day 90
Magnitude of ADA to REGN7508
Time frame: Approximately day 90
Concentrations of REGN7508
Time frame: Approximately day 90
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Cenvacibart