> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/venous-thromboembolism-vte-prophylaxis-with-regn7508-and-e7881e0b-6734-4e83-a9b9-98bc75420812 > Record changed: 2026-10-13 # Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC) NCT07697599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) Participants 1,908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) Start date 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Title and summary **Summary** 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: \* What side effects may happen from taking the study drugs \* How much study drug is in the blood at different times \* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) \* If the study drugs affect the ability of the blood to clot normally Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Acronym** ROXI-PEAK Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Short title** Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Official title** A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Dates **Completion date** 2029-09-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **First posted** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Registry last updated** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Primary completion date** 2029-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Start date** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Size and sites **Participants** 1,908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Planned participants** 1,908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Identifiers **Registry ID** NCT07697599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **ClinicalTrials.gov ID** NCT07697599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Outcomes ### Primary outcomes 1. Time-to-first event of centrally adjudicated VTE \[symptomatic VTE or incidental VTE or asymptomatic VTE\] Timeframe: Approximately 6 months 2. Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding Timeframe: Approximately 6 months ### Secondary outcomes 1. Time-to-first event of centrally adjudicated symptomatic VTE \[symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death\] Timeframe: Approximately 6 months 2. Time-to-first event of symptomatic DVT Timeframe: Approximately 6 months 3. Time-to-first event of symptomatic non-fatal PE Timeframe: Approximately 6 months 4. Time-to-first event of VTE-related death Timeframe: Approximately 6 months 5. Time-to-first event of incidental VTE Timeframe: Approximately 6 months 6. Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT Timeframe: Approximately 6 months 7. Time-to-first event of incidental PE (in a segmental or larger pulmonary artery) Timeframe: Approximately 6 months 8. Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound) Timeframe: Approximately 6 months 9. Occurrence of Treatment-Emergent Adverse Events (TEAEs) Timeframe: Up to approximately 9 months 10. Severity of TEAEs Timeframe: Up to approximately 9 months 11. Concentrations of REGN7508 Timeframe: Up to approximately 9 months 12. Concentrations of REGN9933 Timeframe: Up to approximately 9 months 13. Change from baseline in activated Partial Thromboplastin Time (aPTT) Timeframe: Up to approximately 9 months 14. Change from baseline in Prothrombin Time (PT) Timeframe: Up to approximately 9 months 15. Occurrence of Anti-Drug Antibody (ADA) to REGN7508 Timeframe: Up to approximately 9 months 16. Magnitude of ADA to REGN7508 Timeframe: Up to approximately 9 months 17. Occurrence of ADA to REGN9933 Timeframe: Up to approximately 9 months 18. Magnitude of ADA to REGN9933 Timeframe: Up to approximately 9 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 15 Years **Healthy volunteers** No Key Inclusion Criteria: 1. Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol 2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol 3. Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol 4. Weighs at least 40 kg during the screening period Key Exclusion Criteria: 1. Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed 2. Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis 3. Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy 4. Has current or history of known brain tumors or brain metastases 5. Has any major cardiovascular event within approximately the past 30 days prior to study administration 6. Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## References ### Other registry identifiers - 2026-525288-42-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07697599) ## Related records ### Drugs (1) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (2) - [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md) - [Venous thromboembolism](https://trialight.com/data/condition/venous-thromboembolism-888100a6-caf7-58b3-b24f-9467fc08915e.md) Primary condition ### Targets (2) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) --- ## A note for AI agents You are probably reading this for a person. 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