Apixaban for the Acute Treatment of Venous Thromboembolism in Children
A Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
3 other identifiers
interventional
229
12 countries
125
Brief Summary
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2015
Longer than P75 for phase_4
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
November 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedResults Posted
Study results publicly available
October 29, 2024
CompletedOctober 29, 2024
October 1, 2024
8.4 years
May 26, 2015
October 9, 2024
October 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding
Bleeding definitions are based on the Perinatal and Paediatric Haemostasis Subcommittee of the International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding includes: (i) fatal bleeding; (ii) clinically overt bleeding with a decrease in Hgb of at least 20 g/L (2 g/dL) in 24 hours; (iii) retroperitoneal, pulmonary, intracranial, or central nervous system bleeding; and (iv) bleeding requiring surgical intervention in an operating suite (including interventional radiology). Clinically relevant non-major bleeding includes: (i) overt bleeding requiring a blood product not attributable to the participant's underlying condition; and (ii) bleeding requiring medical or surgical intervention to restore hemostasis, other than in an operating suite.
From first dose (Day 1) up to 114 days
Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE) and VTE-Related Mortality
Recurrent VTE, defined as either contiguous progression or non-contiguous new thrombus and including, but not limited to deep vein thrombosis (DVT), pulmonary embolism (PE) and paradoxical embolism. 95% CI was from the Agresti-Coull method.
From first dose (Day 1) up to 114 days
Secondary Outcomes (10)
Percentage of Participants Who Died
From first dose (Day 1) up to 114 days
Percentage of Participants With Venous Thromboembolism (VTE)-Related Mortality
From first dose (Day 1) up to 114 days
Number of Participants With Index Venous Thromboembolism (VTE) Status
From first dose (Day 1) up to 91 days
Percentage of Participants With Stroke
From first dose (Day 1) up to 114 days
Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE)
From first dose (Day 1) up to 114 days
- +5 more secondary outcomes
Study Arms (1)
Apixaban
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 and are currently tolerating enteric medications, as per investigator's judgement.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (128)
Pediatric Cardiology Clinic
Birmingham, Alabama, 35233, United States
University of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Loma Linda University Cancer Center
Loma Linda, California, 92350, United States
Loma Linda University Children's Hospital
Loma Linda, California, 92354, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Valley Children's Hospital
Madera, California, 93636, United States
Children's Hospital and Research Center Oakland
Oakland, California, 94609, United States
Bass Speicalty Pharmacy
Palo Alto, California, 94304, United States
Inpatient Pharmacy
Palo Alto, California, 94304, United States
Lucile Packard Children's Hosptial - Stanford University
Palo Alto, California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Loma Linda University Health Care
San Bernardino, California, 92408, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94158, United States
UCSF Mission Bay Pediatric Clinical Research Center
San Francisco, California, 94158, United States
Children's Hospital Colorado - Investigational Drug Services
Aurora, Colorado, 80045, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center Pharmacy
Hartford, Connecticut, 06106, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Nemours/ Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
UF Health Shands Hospital
Gainesville, Florida, 32610, United States
JDCH Division of Pediatric Hematology and Oncology
Hollywood, Florida, 33021, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
AdventHealth Orlando-Pharmacy Investigational Drug Services
Orlando, Florida, 32804, United States
AdventHealth Pediatric Oncology Hematology at Orlando
Orlando, Florida, 32804, United States
St. Joseph's Hospital
Tampa, Florida, 33607, United States
Children's Hematology and Oncology a division of Kidz medical Service
West Palm Beach, Florida, 33407, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, 30322, United States
Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit
Atlanta, Georgia, 30329, United States
Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy
Atlanta, Georgia, 30329, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61614, United States
Unity Point Methodist Medical Center
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Indiana University
Indianapolis, Indiana, 46202-5225, United States
IU Health Pharmacy
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center
New York, New York, 10032, United States
New York-Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Levine Children's Specialty Center
Charlotte, North Carolina, 28203, United States
Levine Children's Hospital, Pediatric Research
Charlotte, North Carolina, 28207, United States
Levine Children's Hospital
Charlotte, North Carolina, 28207, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Investigational Drug Service, Duke University Hospital
Durham, North Carolina, 27710, United States
Sanford Children's Hospital
Fargo, North Dakota, 58104, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
OU Medical Center Investigational Drug Pharmacy
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina: Investigational Drug Services
Charleston, South Carolina, 29425, United States
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-7610, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Children's Hospital- Main Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital- Wallace Tower
Houston, Texas, 77030, United States
The Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
University of Texas Health San Antonio
San Antonio, Texas, 78229, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Versiti Wisconsin
Milwaukee, Wisconsin, 53226, United States
Kids Cancer Centre
Randwick, New South Wales, 2031, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
The Royal Childrens Hospital
Parkville, VC, 3052, Australia
A.o.Landeskrankenhaus Innsbruck
Innsbruck, Tyrol, 6020, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Kaye Edmonton Clinic
Edmonton, Alberta, T6G 1Z1, Canada
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
Hamilton Health Science Corporation/McMaster Children's Hospital
Hamilton, Ontario, L8N3Z5, Canada
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Hopital de la Timone Enfants
Marseille, 13385, France
CHRU de Montpellier - Hopital Arnaud de Villeneuve
Montpellier, 34295, France
Hopital Necker-Enfants malades
Paris, 75015, France
CHU de Bordeaux - Hopital Haut-Leveque
Pessac, 33604, France
Service d'Imagerie Medicale du Pr F. Laurent
Pessac, 33604, France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, 13353, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Technische Universitat, Deutsches Herzzentrum Munchen
München, 80636, Germany
Hadassah Medical Center (Ein Kerem)
Jerusalem, 9112001, Israel
O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Instituto Nacional De Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of
Kazan', Republic Tatarstan, 420138, Russia
State Autonomous Healthcare Institution of Sverdlovsk Region
Yekaterinburg, Sverdlovsk Oblast, 620149, Russia
FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia
Moscow, 117198, Russia
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660, Spain
Hospital Universitario Vall d´Hebron
Barcelona, 08035, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Adana Acibadem Hospital
Seyhan, Adana, 01130, Turkey (Türkiye)
Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD
Bahçelievler, Ankara, 06490, Turkey (Türkiye)
Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's Hospital
Ankara, 06230, Turkey (Türkiye)
Ankara City Hospital Pediatric Hematology and Oncology Clinic
Ankara, 06800, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali
Izmir, 35100, Turkey (Türkiye)
Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child
Dnipro, 49006, Ukraine
Dnipropetrovsk Regional Children's Hospital
Dnipro, 49100, Ukraine
Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"
Dnipro, 49100, Ukraine
Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"
Zaporizhzhia, 69063, Ukraine
Royal Hospital for Children
Glasgow, Scotland, G51 4TF, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, TYNE & WEAR, NE1 4LP, United Kingdom
Cardiff & Vale NHS Health Board
Cardiff, Wales, CF14 4XW, United Kingdom
Noah's Ark Children's Hospital for Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, WEST Midlands, B4 6NH, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, WEST Midlands, B4 6NH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 8, 2015
Study Start
November 22, 2015
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
October 29, 2024
Results First Posted
October 29, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
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.