A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT06299111
- Phase
- PHASE2
- Status
- Completed
Conditions
- Venous Thromboembolism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- REGN9933 — DRUGIntravenous (IV) single dose administered
- REGN7508 — DRUGIV single dose administered
- Placebo — DRUGIV single dose administered
Study Details
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: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Key Dates
- Start date
- Sep 20, 2024
- Status verified
- Apr 2026
- Primary completion
- Mar 27, 2026
- Completion
- Mar 27, 2026
Study Design
- Enrollment
- 195 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: REGN9933Randomized 1:1:1
- Experimental: REGN7508Randomized 1:1:1
- Placebo Comparator: PlaceboRandomized 1:1:1
Primary Outcome Measure
Incidence of confirmed VTE per central reading center (CRC) review [ Time Frame: Through Day 14 ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | - |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | - |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | - |
| Henry Ford Health System | Detroit | Michigan | 48202 | - |
| Memorial Sloan Kettering | New York | New York | 10065 | - |
| Mount Sinai Medical Center | New York | New York | 10029 | - |
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