A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants

Last updated: June 4, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Thromboembolism

Blood Clots

Venous Thromboembolism

Treatment

Enoxaparin

Apixiban

REGN9933

Clinical Study ID

NCT05618808
R9933-DVT-2230
2022-501470-18-00
  • Ages > 50
  • All Genders

Study Summary

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin

The secondary objectives of the study are:

  • To evaluate the bleeding risk (ie, major and clinically relevant non-major [CRNM] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin

  • To assess overall safety and tolerability of REGN9933 in participants undergoing TKA

  • To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin

  • To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin

  • To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration

  • To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways

  • To assess immunogenicity following a single dose of REGN9933 over time

  • To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Undergoing elective unilateral TKA

  2. Has a body weight ≤130 kg at screening visit

  3. Is judged by the investigator to be in good health based on medical history,physical examination, vital sign measurements, and Electrocardiograms (ECG)performed at screening and/or prior to administration of initial dose of study drug

  4. Is in good health based on laboratory safety testing obtained during the screeningperiod as described in the protocol

Exclusion

Key Exclusion Criteria:

  1. History of bleeding in the past 6 months requiring hospitalization or transfusion;history of intracranial or intraocular bleeding, excessive operative orpost-operative bleeding, and traumatic spinal or epidural anesthesia; history ofbleeding diathesis.

  2. History of thromboembolic disease or thrombophilia

  3. History of major surgery, including brain, spinal, or ocular, within approximatelythe past 6 months.

  4. History of major trauma within approximately the past 6 months.

  5. Hospitalized (>24 hours) for any reason within 30 days of the screening visit

  6. Using the Modification of Diet in Renal Disease equation, has an estimatedglomerular filtration rate as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study Design

Total Participants: 373
Treatment Group(s): 3
Primary Treatment: Enoxaparin
Phase: 2
Study Start date:
May 24, 2023
Estimated Completion Date:
May 27, 2024

Connect with a study center

  • Ziekenhuis Oost-Limburg- Campus Sint-Jan

    Genk, Limburg 3600
    Belgium

    Site Not Available

  • MBAL Heart and Brain Hospital

    Pleven, 5800
    Bulgaria

    Site Not Available

  • UMHAT St. Georgi EAD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Durham Bone and Join Specialists

    Ajax, Ontario L1S 7K7
    Canada

    Active - Recruiting

  • Durham Bone and Joint Specialists

    Ajax, Ontario L1S 7K7
    Canada

    Site Not Available

  • Hamilton Health Sciences, Juravinski Hospital

    Hamilton, Ontario L8V 1C3
    Canada

    Site Not Available

  • MAV Korhaz es Rendelointezet Szolnok

    Szolnok, Jász-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • Budai Irgalmasrendi Korhaz

    Budapest, 1027
    Hungary

    Site Not Available

  • Department of Orthopedics, Somogy County Mór Kaposi Teaching Hospital

    Kaposvar, 7400
    Hungary

    Site Not Available

  • Rambam Health Care Campus - Internal Medicine

    Haifa, 3109601
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar-Saba, 44281
    Israel

    Site Not Available

  • Beilinson Medical Center

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • Liepaja Regional Hospital

    Liepaja, LV3414
    Latvia

    Site Not Available

  • Hospital of Traumatology and Orthopaedics

    Riga, LV1005
    Latvia

    Site Not Available

  • Riga's 2nd Hospital

    Riga, LV-1004
    Latvia

    Site Not Available

  • Vidzemes Hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno Klinik

    Kaunas, Kauno Apskritis LT-50009
    Lithuania

    Site Not Available

  • Klaipeda University Hospital

    Klaipeda, Klaipedos Apskritis LT-92288
    Lithuania

    Site Not Available

  • Kaunas Clinical Hospital

    Kaunas, LT-44320
    Lithuania

    Active - Recruiting

  • Lietuvos Sveikatos Mokslu Universiteto Kauno Ligoninė

    Kaunas, LT-44320
    Lithuania

    Site Not Available

  • Specjalistyczny Szpital im. E. Szczeklika w Tarnowie

    Tarnow, Malopolskie 33-100
    Poland

    Site Not Available

  • SP ZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 90-153
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954
    Poland

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Radzyniu Podlaskim

    Radzyn Podlaski, 21-300
    Poland

    Site Not Available

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