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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525288-42-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7508 | Experimental |
| |
| REGN9933 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered per the protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE] | 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 | Approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | Approximately 6 months | |
| Time-to-first event of symptomatic DVT | Approximately 6 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
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
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| REGN9933 | Drug | Administered per the protocol |
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| Placebo | Drug | Administered per the protocol |
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| Time-to-first event of symptomatic non-fatal PE | Approximately 6 months |
| Time-to-first event of VTE-related death | Approximately 6 months |
| Time-to-first event of incidental VTE | Approximately 6 months |
| Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT | Approximately 6 months |
| Time-to-first event of incidental PE (in a segmental or larger pulmonary artery) | Approximately 6 months |
| Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound) | Approximately 6 months |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 9 months |
| Severity of TEAEs | Up to approximately 9 months |
| Concentrations of REGN7508 | Up to approximately 9 months |
| Concentrations of REGN9933 | Up to approximately 9 months |
| Change from baseline in activated Partial Thromboplastin Time (aPTT) | Up to approximately 9 months |
| Change from baseline in Prothrombin Time (PT) | Up to approximately 9 months |
| Occurrence of Anti-Drug Antibody (ADA) to REGN7508 | Up to approximately 9 months |
| Magnitude of ADA to REGN7508 | Up to approximately 9 months |
| Occurrence of ADA to REGN9933 | Up to approximately 9 months |
| Magnitude of ADA to REGN9933 | Up to approximately 9 months |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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