Apixaban for the Acute Treatment of Venous Thromboembolism in Children

October 9, 2024 updated by: Bristol-Myers Squibb

A Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
229

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Kids Cancer Centre
      • Sydney, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • The Royal Childrens Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universitaet Innsbruck
      • Wien, Austria, 1090
        • Medizinische Universitaet Wien
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • A.o.Landeskrankenhaus Innsbruck
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Kaye Edmonton Clinic
    • Ontario
      • Hamilton, Ontario, Canada, L8N3Z5
        • Hamilton Health Science Corporation/McMaster Children's Hospital
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
  • France
      • Marseille, France, 13385
        • Hôpital de la Timone Enfants
      • Montpellier Cedex 5, France, 34295
        • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
      • PESSAC Cedex, France, 33604
        • Chu de Bordeaux - Hopital Haut-Leveque
      • PESSAC Cedex, France, 33604
        • Service d'Imagerie Medicale du Pr F. Laurent
      • Paris, France, 75015
        • Hôpital Necker-Enfants Malades
  • Germany
      • Berlin, Germany, 13353
        • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
      • Munchen, Germany, 80636
        • Technische Universitat, Deutsches Herzzentrum Munchen
  • Israel
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center (Ein Kerem)
  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde
  • Russian Federation
      • Moscow, Russian Federation, 117198
        • FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia
    • Republic Tatarstan
      • Kazan, Republic Tatarstan, Russian Federation, 420138
        • State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of
    • Sverdlovsk Region
      • Yekaterinburg, Sverdlovsk Region, Russian Federation, 620149
        • State Autonomous Healthcare Institution of Sverdlovsk Region
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d´Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu
    • Madrid
      • Boadilla del Monte, Madrid, Spain, 28660
        • Hospital Universitario HM Monteprincipe
  • Turkey
      • Ankara, Turkey, 06230
        • Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's Hospital
      • Ankara, Turkey, 06800
        • Ankara City Hospital Pediatric Hematology and Oncology Clinic
      • Izmir, Turkey, 35100
        • Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali
    • Adana
      • Seyhan, Adana, Turkey, 01130
        • Adana Acibadem Hospital
    • Ankara
      • Bahcelievler, Ankara, Turkey, 06490
        • Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD
  • Ukraine
      • Dnipro, Ukraine, 49006
        • Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child
      • Dnipro, Ukraine, 49100
        • Dnipropetrovsk Regional Children's Hospital
      • Dnipro, Ukraine, 49100
        • Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"
      • Zaporizhzhia, Ukraine, 69063
        • Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"
  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Royal Hospital For Children
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
    • WEST Midlands
      • Birmingham, WEST Midlands, United Kingdom, B4 6NH
        • Birmingham Children's Hospital NHS Foundation Trust
      • Birmingham, WEST Midlands, United Kingdom, B4 6NH
        • Birmingham Women's and Children's NHS Foundation Trust
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • Cardiff & Vale NHS Health Board
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • Noah's Ark Children's Hospital for Wales
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
      • Birmingham, Alabama, United States, 35233
        • Pediatric Cardiology Clinic
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Children's Hospital
      • Loma Linda, California, United States, 92350
        • Loma Linda University Cancer Center
      • Madera, California, United States, 93636
        • Valley Children's Hospital
      • Oakland, California, United States, 94609
        • Children's Hospital and Research Center Oakland
      • Palo Alto, California, United States, 94304
        • Bass Speicalty Pharmacy
      • Palo Alto, California, United States, 94304
        • Inpatient Pharmacy
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hosptial - Stanford University
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Bernardino, California, United States, 92408
        • Loma Linda University Health Care
      • San Francisco, California, United States, 94158
        • UCSF Benioff Children's Hospital
      • San Francisco, California, United States, 94158
        • UCSF Mission Bay Pediatric Clinical Research Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado - Investigational Drug Services
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center Pharmacy
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours/ Alfred I. duPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Childrens National Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health Shands Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Hollywood, Florida, United States, 33021
        • Joe DiMaggio Children's Hospital
      • Hollywood, Florida, United States, 33021
        • JDCH Division of Pediatric Hematology and Oncology
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Orlando, Florida, United States, 32804
        • AdventHealth Pediatric Oncology Hematology at Orlando
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando-Pharmacy Investigational Drug Services
      • Tampa, Florida, United States, 33607
        • St. Joseph's Hospital
      • West Palm Beach, Florida, United States, 33407
        • St. Mary's Medical Center
      • West Palm Beach, Florida, United States, 33407
        • Children's Hematology and Oncology a division of Kidz medical Service
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta-Egleston
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Children's Hospital of Chicago
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61614
        • Bleeding and Clotting Disorders Institute
      • Peoria, Illinois, United States, 61636
        • Unity Point Methodist Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children at IU Health
      • Indianapolis, Indiana, United States, 46202
        • IU Health Pharmacy
      • Indianapolis, Indiana, United States, 46202-5225
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10032
        • New York-Presbyterian Morgan Stanley Children's Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Levine Children's Hospital
      • Charlotte, North Carolina, United States, 28203
        • Levine Children's Specialty Center
      • Charlotte, North Carolina, United States, 28207
        • Levine Children's Hospital, Pediatric Research
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27710
        • Investigational Drug Service, Duke University Hospital
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58104
        • Sanford Children's Hospital
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Medical Center Investigational Drug Pharmacy
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Children's Hospital of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina: Investigational Drug Services
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37232
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
      • Nashville, Tennessee, United States, 37232-7610
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital- Wallace Tower
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital- Main Hospital
      • San Antonio, Texas, United States, 78229
        • University of Texas Health San Antonio
      • San Antonio, Texas, United States, 78207
        • The Children's Hospital of San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Versiti Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization.
  2. Presence of an index VTE which is confirmed by imaging.
  3. Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks.
  4. Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator's judgement.

Exclusion Criteria:

  1. 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.
  2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE.
  3. A mechanical heart valve.
  4. Active bleeding or high risk of bleeding at the time of randomization.
  5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.
  6. Abnormal baseline liver function at randomization.
  7. Inadequate renal function at the time of randomization.
  8. Platelet count <50×109 per L at randomization.
  9. Uncontrolled severe hypertension at the time of randomization.
  10. Use of prohibited concomitant medication at the time of randomization.
  11. Female subjects who are either pregnant or breastfeeding a child.
  12. Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment.
  13. Unable to take oral or enteric medication via the NG or G tube.
  14. Known inherited or acquired antiphospholipid syndrome (APS).
  15. Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding
Time Frame: From first dose (Day 1) up to 114 days
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
Time Frame: From first dose (Day 1) up to 114 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Died
Time Frame: From first dose (Day 1) up to 114 days
Death due to any cause was assessed. 95% CI was calculated using the Agresti-Coull method.
From first dose (Day 1) up to 114 days
Percentage of Participants With Venous Thromboembolism (VTE)-Related Mortality
Time Frame: From first dose (Day 1) up to 114 days
Participants were assessed for death due to Venous Thromboembolism (VTE).
From first dose (Day 1) up to 114 days
Number of Participants With Index Venous Thromboembolism (VTE) Status
Time Frame: From first dose (Day 1) up to 91 days
Index VTE status was defined as the last image obtained during the Main treatment phase for each participant's comparison to baseline imaging. Index VTE status was classified as Recurrence-contiguous; Recurrence-new; Unchanged; Regression; Resolution; Indeterminate/Nondiagnostic. Participants could have multiple concomitant index events. Regression was defined as (ie, unequivocal decrease [>50%] of the total volume/mass of the thrombus compared to the index event)
From first dose (Day 1) up to 91 days
Percentage of Participants With Stroke
Time Frame: From first dose (Day 1) up to 114 days
Participants were assessed for incidence of stroke.
From first dose (Day 1) up to 114 days
Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE)
Time Frame: From first dose (Day 1) up to 114 days
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
Number of Participants With New Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) and New Symptomatic or Asymptomatic Pulmonary Embolism (PE)
Time Frame: From first dose (Day 1) up to 114 days
Participants were assessed for incidence of Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) and New Symptomatic or Asymptomatic Pulmonary Embolism (PE).
From first dose (Day 1) up to 114 days
Percentage of Participants With Other Symptomatic and Asymptomatic Venous Thromboembolism (VTE)
Time Frame: From first dose (Day 1) up to 114 days
Other VTE included events such as cerebral sinovenous thrombosis, renal vein thrombosis, portal vein thrombosis, catheter-related VTE, and splanchnic thrombosis. If VTE event type was blank, it was included in the Other VTE. 95% CI was from the Agresti-Coull method.
From first dose (Day 1) up to 114 days
Number of Participants With Clinically Relevant Non-Major (CRNM) Bleeding, Major Bleeding and Minor Bleeding
Time Frame: From first dose (Day 1) up to 114 days
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. Minor bleeding was defined as any overt or macroscopic evidence of bleeding that does not fulfill the above criteria for either major bleeding or clinically relevant, non-major bleeding.
From first dose (Day 1) up to 114 days
Blood Concentration of Apixaban (ng/mL)
Time Frame: 3 hour (H), 12 H, 24 H at Day 3; pre and post dose at Day 14 and Day 42
Blood samples were collected to assess the apixaban concentration at specified timepoints. Day 1 PK concentrations were only collected for participants in the Birth to ≤27 days arm. The lower limit of quantification (LLOQ) is 1.0 ng/mL for plasma samples, and 0.5 ng/mL for dried blood samples.
3 hour (H), 12 H, 24 H at Day 3; pre and post dose at Day 14 and Day 42
Concentration of Plasma Anti-Factor Xa (ng/mL)
Time Frame: Pre and post dose at Day 14 and Day 42
Blood samples were collected to assess the Anti-Factor Xa concentration at specified timepoints. Day 1 PK concentrations were only collected for participants in the Birth to ≤27 days arm. The lower limit of quantification (LLOQ) is 35.0 ng/mL.
Pre and post dose at Day 14 and Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B0661037
  • 2014-002606-20 (EudraCT Number)
  • CV185-325 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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