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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508603-21-00 | EU Trial (CTIS) Number |
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This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN9933 | Experimental | Randomized 1:1:1 |
|
| REGN7508 | Experimental | Randomized 1:1:1 |
|
| Placebo | Placebo Comparator | Randomized 1:1:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN9933 | Drug | Intravenous (IV) single dose administered |
| |
| REGN7508 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of confirmed VTE per central reading center (CRC) review | Through Day 14 | |
| Incidence of treatment-emergent adverse event (TEAEs) | Up to Day 100 | |
| Severity of TEAEs | Up to Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of confirmed PICC associated venous thrombosis per CRC review | Through Day 14 | |
| Incidence of major bleeding | Through Day 14 | |
| Incidence of clinically relevant non-major (CRNM) bleeding |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Sylvester Comprehensive Cancer Center |
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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| Drug |
IV single dose administered |
|
| Placebo | Drug | IV single dose administered |
|
| Through Day 14 |
| Concentrations of REGN9933 in serum | Up to Day 75 |
| Concentrations of REGN7508 in serum | Up to Day 75 |
| Change in activated partial thromboplastin time (aPTT) | Up to Day 75 |
| Change in prothrombin time (PT) | Up to Day 75 |
| Incidence of anti-drug antibody (ADA) to REGN9933 over time | Up to Day 75 |
| Magnitude of ADA to REGN9933 over time | Up to Day 75 |
| Incidence of ADA to REGN7508 over time | Up to Day 75 |
| Magnitude of ADA to REGN7508 over time | Up to Day 75 |
| Miami |
| Florida |
| 33136 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Memorial Sloan Kettering | New York | New York | 10065 | United States |
| Sveta Sofia Hospital | Sofia | 1000 | Bulgaria |
| Juravinski Hospital | Hamilton | Ontario | L8V 1C3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Lakeridge Health | Oshawa | Ontario | L1G 2B9 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Shaare Zedek Medical Center | Jerusalem | Jerusalem | 9103102 | Israel |
| Soroka University Medical Center | Beersheba | Southern District | 84101 | Israel |
| Hadassah University Medical Center | Jerusalem | 91120 | Israel |
| Lanadio Medical Center | Netanya | 4244916 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Arensia Research Clinic | Bucharest | 011658 | Romania |
| Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca | Cluj-Napoca | 400006 | Romania |
| University hospital Southampton | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Cardiff and Vale University Health Board - University Hospital Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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