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)

Last updated: March 24, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Venous Thromboembolism

Venous Thrombosis

Blood Clots

Treatment

Placebo

REGN7508

REGN9933

Clinical Study ID

NCT06299111
R9933-DVT-2308
2023-508603-21-00
  • Ages > 18
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. PICC is anticipated to remain in place for at least 14 days

  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalentfunctional status as described in the protocol

  3. Body weight ≥50 kg and ≤130 kg during the screening period

  4. International normalized ratio (INR) and aPTT values at or below the upper limit ofnormal as defined by the local lab during the screening period

  5. Platelet count ≥100 x 10^9/L during the screening period as described in theprotocol

Exclusion

Key Exclusion Criteria:

  1. Unsuccessful PICC placement or any other complication associated with this procedurethat in the opinion of the study investigator may present any safety concerns to theparticipant

  2. History of prior venous thrombosis in the arm in which the PICC is to be placed

  3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expectedneed for peripheral catheter(s) placement in the same arm the PICC is to be placedas described in the protocol

  4. History of known thromboembolic disease or thrombophilia

  5. Participants requiring therapeutic or prophylactic anticoagulation and/orantiplatelet therapy as described in the protocol

  6. Expected to receive cancer therapy or other medication associated with a priorepisode of Grade 4 thrombocytopenia as described in the protocol

  7. Any history of intracranial or intraocular bleeding, excessive operative orpost-operative bleeding, traumatic spinal or epidural anesthesia, or history ofbleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand'sdisease, fibrinogen deficiency, and other inherited or acquired bleeding disorders)

Note: Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 195
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 20, 2024
Estimated Completion Date:
June 29, 2026

Connect with a study center

  • Sveta Sofia Hospital

    Sofia, 1000
    Bulgaria

    Active - Recruiting

  • Lakeridge Health

    Oshawa, Ontario L1G 2B9
    Canada

    Active - Recruiting

  • Soroka University Medical Center

    Beer-Sheba, HaDarom 84101
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9103102
    Israel

    Active - Recruiting

  • Hadassah University Medical Center

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Lanadio Medical Center

    Netanya, 4244916
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 49100
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca

    Cluj-Napoca, 400006
    Romania

    Active - Recruiting

  • Memorial Sloan Kettering

    New York, New York 10065
    United States

    Active - Recruiting

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