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 — DRUG
    Intravenous (IV) single dose administered
  • REGN7508 — DRUG
    IV single dose administered
  • Placebo — DRUG
    IV 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: REGN9933
    Randomized 1:1:1
  • Experimental: REGN7508
    Randomized 1:1:1
  • Placebo Comparator: Placebo
    Randomized 1:1:1

Primary Outcome Measure

Incidence of confirmed VTE per central reading center (CRC) review [ Time Frame: Through Day 14 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Brigham and Women's HospitalBostonMassachusetts02115-
Henry Ford Health SystemDetroitMichigan48202-
Memorial Sloan KetteringNew YorkNew York10065-
Mount Sinai Medical CenterNew YorkNew York10029-

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