A Phase 3 interventional study of REGN7508 and REGN9933 in Venous Thromboembolism (VTE), sponsored by Regeneron Pharmaceuticals. Recruiting at 1 site in Georgia. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter [PICC]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism [VTE]) and lead to serious health problems or be life threatening.
The aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.
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 1,908 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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: REGN7508
Drug: REGN9933
Drug: Placebo
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Time frame: Approximately 6 months
Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
Time frame: Approximately 6 months
Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death]
Time frame: Approximately 6 months
Time-to-first event of symptomatic DVT
Time frame: Approximately 6 months
Time-to-first event of symptomatic non-fatal PE
Time frame: Approximately 6 months
Time-to-first event of VTE-related death
Time frame: Approximately 6 months
Time-to-first event of incidental VTE
Time frame: Approximately 6 months
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Time frame: Approximately 6 months
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
Time frame: Approximately 6 months
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
Time frame: Approximately 6 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 9 months
Severity of TEAEs
Time frame: Up to approximately 9 months
Concentrations of REGN7508
Time frame: Up to approximately 9 months
Concentrations of REGN9933
Time frame: Up to approximately 9 months
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Time frame: Up to approximately 9 months
Change from baseline in Prothrombin Time (PT)
Time frame: Up to approximately 9 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Time frame: Up to approximately 9 months
Magnitude of ADA to REGN7508
Time frame: Up to approximately 9 months
Occurrence of ADA to REGN9933
Time frame: Up to approximately 9 months
Magnitude of ADA to REGN9933
Time frame: Up to approximately 9 months
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.
Started Sep 2026 (actual). Primary completion is estimated for Jun 2029, 33 months after the start.
Of 47 phase 3 interventional studies under Venous Thromboembolism, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 33 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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.
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Studies of the drugs tested here: Cenvacibart · Amrecibart