A Phase 3 interventional study of REGN7508 and Acetylsalicylic Acid (ASA) in Symptomatic Venous Thromboembolism (VTE), sponsored by Regeneron Pharmaceuticals. Recruiting at 57 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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 compared to acetylsalicylic acid.
The study is looking at several other research questions, including:
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis 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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: REGN7508 · Drug: Placebo
Drug: Acetylsalicylic Acid (ASA) · Drug: Placebo
Administered per the protocol
Also known as: cenvacibart
Administered per the protocol
Administered per the protocol
Incidence of the composite endpoint of symptomatic VTE and all-cause death
Time frame: Through day 30 visit
Time to first event of the composite endpoint of symptomatic VTE and all-cause death
Time frame: Through day 30 visit
Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)
Time frame: Through day 30 visit
Incidence of confirmed Pulmonary Embolism (PE)
Time frame: Through day 30 visit
Incidence of all-cause death
Time frame: Through day 30 visit
Time to first event of the confirmed symptomatic DVT
Time frame: Through day 30 visit
Time to first event of the confirmed PE
Time frame: Through day 30 visit
Time to the all-cause death
Time frame: Through day 30 visit
Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding
Time frame: Through day 30 visit
Incidence of minor bleeding
Time frame: Through day 30 visit
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through day 90 visit
Severity of TEAEs
Time frame: Through day 90 visit
Incidence of Anti-drug Antibody (ADA) to REGN7508
Time frame: Through day 90 visit
Magnitude of ADA to REGN7508
Time frame: Through day 90 visit
Concentrations of REGN7508
Time frame: Through day 90 visit
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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 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
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.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cenvacibart