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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

  • Clinicaltrials.gov identifier

    NCT02464969

  • Recruitment Status

    Recruiting

  • First Posted

    June 8, 2015

  • Last update posted

    December 13, 2021

Study Description

Brief summary:

To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

  • Condition or Disease:Venous Thromboembolism
  • Intervention/Treatment: Drug: Apixaban
    Drug: Standard of Care
  • Phase: Phase 4

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 250 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT
  • Actual Study Start Date: November 2015
  • Estimated Primary Completion Date: April 2023
  • Estimated Study Completion Date: April 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Apixaban
Subjects between birth to <18 years will be dosed on a body weight tiered regimen. Subjects ≥35kg will receive 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg will receive 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg will receive 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg will receive 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg will receive 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg will receive 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg will receive 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg will receive 0.6mg twice daily for 7 days and 0.3mg BID thereafter;PK cohort neonates ≥ 2.6kg will receive 0.1mg BID. Dose will be adjusted as determined by PK measurements (ie, to 0.2mg BID, 0.1mg daily or dose will stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis,subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter.
Drug: Apixaban
Tablet or Solution
Active Comparator: Standard of Care
Subjects will receive a dose and dosing regimen of anticoagulation treatment based on usual and customary care per local practices.
Drug: Standard of Care
Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.

Outcome Measures

  • Primary Outcome Measures: 1. The composite of major and clinically relevant non major bleeding. [ Time Frame: up to 12 weeks ]
    The composite of major and clinically relevant non major bleeding.
  • 2. A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality. [ Time Frame: up to 12 weeks ]
    A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.
  • Secondary Outcome Measures: 1. Apixaban concentration [ Time Frame: Day 14 ]
    Apixaban concentration
  • 2. Anti-Xa Levels [ Time Frame: Day 14 ]
    Anti-Xa Levels

Eligibility Criteria

  • Ages Eligible for Study: up to 17 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization. Presence of an index VTE which is confirmed by imaging. Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks. Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding for at least 5 days. Exclusion Criteria: Anticoagulant treatment for the index VTE for greater than 14 days prior to randomization. Neonates that are enrolled into the PK cohort must be on a minimum of 5 days and a maximum of 14 days SOC anticoagulation prior to randomization. Neonates that are enrolled into the post PK cohort may receive SOC anticoagulation for up to 14 days prior to randomization. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE. A mechanical heart valve. Active bleeding or high risk of bleeding at the time of randomization. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization. Abnormal baseline liver function at randomization. Inadequate renal function at the time of randomization. Platelet count <50×109 per L at randomization. Uncontrolled severe hypertension at the time of randomization. Use of prohibited concomitant medication at the time of randomization. Female subjects who are either pregnant or breastfeeding a child. Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment. Unable to take oral or enteric medication via the NG or G tube. Known inherited or acquired antiphospholipid syndrome (APS). Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

United States, Alabama
Pediatric Cardiology Clinic
Birmingham

United States, Alabama
University of Alabama
Birmingham

United States, Arizona
Phoenix Children's Hospital
Phoenix

United States, California
Loma Linda University Cancer Center
Loma Linda

United States, California
Loma Linda University Children's Hospital
Loma Linda

United States, California
Loma Linda University Medical Center
Loma Linda

United States, California
Valley Children's Hospital
Madera

United States, California
Children's Hospital and Research Center Oakland
Oakland

United States, California
Kaiser Permanente-Oakland c/o Kris Nishimura, Pharm. D
Oakland

United States, California
Kaiser Permanente
Oakland

United States, California
Bass Speicalty Pharmacy
Palo Alto

United States, California
Inpatient Pharmacy
Palo Alto

United States, California
Lucile Packard Children's Hosptial - Stanford University
Palo Alto

United States, California
Kaiser Permanente Roseville Medical Center
Roseville

United States, California
University of California Davis Comprehensive Cancer Center
Sacramento

United States, California
Loma Linda University Health Care
San Bernardino

United States, California
UCSF Benioff Children's Hospital
San Francisco

United States, California
UCSF Mission Bay Investigational Drug Pharmacy
San Francisco

United States, California
UCSF Mission Bay Pediatric Clinical Research Center
San Francisco

United States, Colorado
Children's Hospital Colorado - Investigational Drug Services
Aurora

United States, Colorado
Children's Hospital Colorado
Aurora

United States, Connecticut
Connecticut Children's Medical Center Pharmacy
Hartford

United States, Connecticut
Connecticut Children's Medical Center
Hartford

United States, Delaware
Nemours/ Alfred I. duPont Hospital for Children
Wilmington

United States, District of Columbia
Childrens National Medical Center
Washington

United States, Florida
UF Health Shands Hospital
Gainesville

United States, Florida
JDCH Division of Pediatric Hematology and Oncology
Hollywood

United States, Florida
Joe DiMaggio Children's Hospital
Hollywood

United States, Florida
Memorial Regional Hospital
Hollywood

United States, Florida
Nicklaus Children's Hospital
Miami

United States, Florida
AdventHealth Orlando
Orlando

United States, Florida
AdventHealth Orlando-Pharmacy Investigational Drug Services
Orlando

United States, Florida
AdventHealth Pediatric Oncology Hematology at Orlando
Orlando

United States, Florida
Orlando Health, Inc.
Orlando

United States, Florida
St. Joseph's Hospital
Tampa

United States, Florida
Children's Hematology and Oncology a division of Kidz medical Service
West Palm Beach

United States, Florida
St. Mary's Medical Center
West Palm Beach

United States, Georgia
Children's Healthcare of Atlanta-Egleston
Atlanta

United States, Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit
Atlanta

United States, Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy
Atlanta

United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago

United States, Illinois
Bleeding and Clotting Disorders Institute
Peoria

United States, Illinois
Unity Point Methodist Medical Center
Peoria

United States, Illinois
OSF Saint Francis Medical Center
Peoria

United States, Indiana
Indiana University
Indianapolis

United States, Indiana
IU Health Pharmacy
Indianapolis

United States, Indiana
Riley Hospital for Children at IU Health
Indianapolis

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City

United States, Kentucky
University of Kentucky Medical Center
Lexington

United States, Louisiana
Children's Hospital
New Orleans

United States, Massachusetts
Boston Children's Hospital
Boston

United States, Michigan
University of Michigan
Ann Arbor

United States, Michigan
Children's Hospital of Michigan - Hematology Clinic
Detroit

United States, Michigan
Children's Hospital of Michigan
Detroit

United States, Mississippi
University of Mississippi Medical Center
Jackson

United States, Missouri
Children's Mercy Hospital
Kansas City

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, New York
Columbia University Medical Center
New York

United States, New York
New York-Presbyterian Morgan Stanley Children's Hospital
New York

United States, New York
SUNY Upstate Medical University
Syracuse

United States, North Carolina
Levine Children's Hospital
Charlotte

United States, North Carolina
Levine Children's Specialty Center
Charlotte

United States, North Carolina
Levine Children's Hospital, Pediatric Research
Charlotte

United States, North Carolina
Duke University Medical Center
Durham

United States, North Carolina
Investigational Drug Service, Duke University Hospital
Durham

United States, North Dakota
Sanford Children's Hospital
Fargo

United States, North Dakota
Sanford Roger Maris Cancer Center
Fargo

United States, Ohio
Akron Children's Hospital
Akron

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati

United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland

United States, Ohio
Cleveland Clinic
Cleveland

United States, Ohio
Nationwide Children's Hospital
Columbus

United States, Oklahoma
OU Medical Center Investigational Drug Pharmacy
Oklahoma City

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City

United States, Pennsylvania
The Children's Hospital of Philadelphia - Investigational Pharmacy
Philadelphia

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia

United States, Pennsylvania
St. Christopher's Healthcare d/b/a St. Christopher's Hospital for Children
Philadelphia

United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia

United States, Pennsylvania
UPMC Children's Hospital of Pittsburgh
Pittsburgh

United States, South Carolina
Medical University of South Carolina: Investigational Drug Services
Charleston

United States, South Carolina
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
Charleston

United States, South Carolina
Medical University of South Carolina
Charleston

United States, South Dakota
Sanford Cancer Center Pharmacy
Sioux Falls

United States, South Dakota
Sanford Children's Hospital
Sioux Falls

United States, South Dakota
Sanford Children's Specialty Clinic
Sioux Falls

United States, South Dakota
Sanford USD Medical Center
Sioux Falls

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
Texas Children's Hospital- Main Hospital
Houston

United States, Texas
Texas Children's Hospital- Wallace Tower
Houston

United States, Texas
The Children's Hospital of San Antonio
San Antonio

United States, Texas
University of Texas Health San Antonio
San Antonio

United States, Utah
Primary Children's Hospital
Salt Lake City

United States, Washington
Seattle Children's Hospital
Seattle

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee

United States, Wisconsin
Children's Hospital of Wisconsin Logistics Warehouse
West Allis

Australia, New South Wales
Kids Cancer Centre
Randwick

Australia, New South Wales
Prince of Wales Hospital
Sydney

Australia, Victoria
The Royal Childrens Hospital
Parkville

Austria, Tyrol
A.o.Landeskrankenhaus Innsbruck
Innsbruck

Austria
Medizinische Universitaet Innsbruck
Innsbruck

Austria
Medizinische Universitaet Wien
Wien

Canada, Alberta
Kaye Edmonton Clinic
Edmonton

Canada, Alberta
Stollery Children's Hospital
Edmonton

Canada, Ontario
Hamilton Health Science Corporation/McMaster Children's Hospital
Hamilton

Canada, Ontario
Childrens Hospital of Eastern Ontario
Ottawa

Canada, Ontario
The Hospital For Sick Children
Toronto

Canada, Quebec
CHU Sainte-Justine
Montreal

France
Hopital de la Timone Enfants
Marseille

France
CHRU de Montpellier - Hopital Arnaud de Villeneuve
Montpellier Cedex 5

France
Hopital Necker-Enfants malades
Paris

France
CHU de Bordeaux - Hopital Haut-Leveque
PESSAC Cedex

France
Service d'Imagerie Medicale du Pr F. Laurent
PESSAC Cedex

Germany
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin

Germany
Universitätsklinikum Essen
Essen

Germany
Technische Universitat, Deutsches Herzzentrum Munchen
Munchen

Israel
Soroka University Medical Center -Imaging Unit
Beer Sheva

Israel
Soroka University Medical Center -Pharmacy
Beer Sheva

Israel
Soroka University Medical Center
Beer Sheva

Israel
Hadassah Medical Center (Ein Kerem)
Jerusalem

Russian Federation, Republic Tatarstan
State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of
Kazan

Russian Federation, Sverdlovsk Region
State Autonomous Healthcare Institution of Sverdlovsk Region
Yekaterinburg

Russian Federation
FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia
Moscow

Russian Federation
State Budgetary Healthcare Institution of Moscow city
Moscow

Spain, Barcelona
Hospital Sant Joan de Deu
Esplugues de Llobregat

Spain, Madrid
Hospital Universitario HM Monteprincipe
Boadilla del Monte

Spain
Hospital Universitario Vall d´Hebron
Barcelona

Spain
Hospital Universitario La Paz
Madrid

Ukraine
Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child
Dnipro

Ukraine
Dnipropetrovsk Regional Children's Hospital
Dnipro

Ukraine
Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"
Dnipro

Ukraine
Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"
Zaporizhzhia

United Kingdom, Scotland
Royal Hospital for Children
Glasgow

United Kingdom, Tyne & Wear
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne

United Kingdom, Wales
Cardiff & Vale NHS Health Board
Cardiff

United Kingdom, Wales
Noah's Ark Children's Hospital for Wales
Cardiff

United Kingdom, WEST Midlands
Birmingham Women's and Children's NHS Foundation Trust
Birmingham

United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham

Sponsors and Collaborators

Pfizer

Bristol-Myers Squibb

Investigators

Study Director: Pfizer CT.gov Call Center Pfizer

More Information

  • Responsible Party: Pfizer
  • ClinicalTrials.gov Identifier: NCT02464969 History of Changes
  • Other Study ID Numbers: B0661037, 2014-002606-20, CV185-325
  • First Posted: June 8, 2015 Key Record Dates
  • Last Update Posted: December 13, 2021
  • Last Verified: December 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
  • URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
  • Keywords provided by Pfizer: VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis
  • Additional relevant MeSH terms: Thromboembolism
    Venous Thromboembolism
    Embolism and Thrombosis
    Vascular Diseases
    Cardiovascular Diseases