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: January 9, 2026
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Venous Thromboembolism

Venous Thrombosis

Thromboembolism

Treatment

Placebo

REGN9933

REGN7508

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 clinically indicated for at least 14 days and is anticipated to remain inplace 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 ≥45 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 anticoagulation and/or antiplatelet therapy asdescribed 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)as described in the protocol

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 01, 2026

Connect with a study center

  • SVETA Sofia Hospital

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Sveta Sofia Hospital

    Sofia 727011, 1000
    Bulgaria

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 4L6
    Canada

    Site Not Available

  • Lakeridge Health

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Juravinski Hospital

    Hamilton 5969782, Ontario 6093943 L8V 1C3
    Canada

    Site Not Available

  • London Health Sciences Centre

    London 6058560, Ontario 6093943 N6A 4L6
    Canada

    Site Not Available

  • Lakeridge Health

    Oshawa 6094578, Ontario 6093943 L1G 2B9
    Canada

    Site Not Available

  • University Health Network

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Soroka University Medical Center

    Beer-Sheba, HaDarom 84101
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem 281184, Jerusalem 293198 9103102
    Israel

    Site Not Available

  • Soroka University Medical Center

    Beersheba 295530, Southern District 294952 84101
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9103102
    Israel

    Site Not Available

  • Hadassah University Medical Center

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Hadassah University Medical Center

    Jerusalem 281184, 91120
    Israel

    Site Not Available

  • Lanadio Medical Center

    Netanya, 4244916
    Israel

    Site Not Available

  • Lanadio Medical Center

    Netanya 294071, 4244916
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, 49100
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva 293918, 49100
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan 293788, 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv 293397, 64239
    Israel

    Site Not Available

  • Arensia Research Clinic

    Bucharest 683506, 011658
    Romania

    Site Not Available

  • ARENSIA Exploratory Medicine Clinic at Country Hospital Cluj-Napoca

    Cluj-Napoca, 400006
    Romania

    Site Not Available

  • Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca

    Cluj-Napoca 681290, 400006
    Romania

    Site Not Available

  • University hospital Southampton

    Southampton 2637487, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Cardiff and Vale University Health Board - University Hospital Wales

    Cardiff, Wales Cf14 4Xw
    United Kingdom

    Site Not Available

  • Cardiff and Vale University Health Board - University Hospital Wales

    Cardiff 2653822, Wales 2634895 CF14 4XW
    United Kingdom

    Site Not Available

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne 2641673, NE1 4LP
    United Kingdom

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

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