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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Primary Purpose

Venous Thromboembolism

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Apixaban
Standard of Care
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis

Eligibility Criteria

0 Days - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Pediatric Cardiology ClinicRecruiting
  • University of AlabamaRecruiting
  • Phoenix Children's Hospital
  • Loma Linda University Cancer Center
  • Loma Linda University Children's Hospital
  • Loma Linda University Medical Center
  • Valley Children's Hospital
  • Children's Hospital and Research Center Oakland
  • Bass Speicalty PharmacyRecruiting
  • Inpatient PharmacyRecruiting
  • Lucile Packard Children's Hosptial - Stanford UniversityRecruiting
  • University of California Davis Comprehensive Cancer CenterRecruiting
  • Loma Linda University Health Care
  • UCSF Benioff Children's HospitalRecruiting
  • UCSF Mission Bay Pediatric Clinical Research CenterRecruiting
  • Children's Hospital Colorado - Investigational Drug Services
  • Children's Hospital Colorado
  • Connecticut Children's Medical Center Pharmacy
  • Connecticut Children's Medical Center
  • Nemours/ Alfred I. duPont Hospital for ChildrenRecruiting
  • Childrens National Medical Center
  • UF Health Shands Hospital
  • JDCH Division of Pediatric Hematology and Oncology
  • Joe DiMaggio Children's Hospital
  • Memorial Regional Hospital
  • Nicklaus Children's Hospital
  • AdventHealth Orlando
  • AdventHealth Orlando-Pharmacy Investigational Drug Services
  • AdventHealth Pediatric Oncology Hematology at Orlando
  • St. Joseph's HospitalRecruiting
  • Children's Hematology and Oncology a division of Kidz medical Service
  • St. Mary's Medical Center
  • Children's Healthcare of Atlanta-EglestonRecruiting
  • Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research UnitRecruiting
  • Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS PharmacyRecruiting
  • Ann & Robert H Lurie Children's Hospital of ChicagoRecruiting
  • Bleeding and Clotting Disorders Institute
  • Unity Point Methodist Medical Center
  • OSF Saint Francis Medical Center
  • Indiana University
  • IU Health Pharmacy
  • Riley Hospital for Children at IU Health
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of Kentucky Medical CenterRecruiting
  • Boston Children's HospitalRecruiting
  • University of Michigan
  • Children's Hospital of MichiganRecruiting
  • University of Mississippi Medical Center
  • Children's Mercy Hospital
  • Hackensack University Medical Center
  • Columbia University Medical Center
  • New York-Presbyterian Morgan Stanley Children's Hospital
  • SUNY Upstate Medical University
  • Levine Children's Specialty Center
  • Levine Children's Hospital, Pediatric Research
  • Levine Children's Hospital
  • Duke University Medical CenterRecruiting
  • Investigational Drug Service, Duke University HospitalRecruiting
  • Sanford Children's Hospital
  • Sanford Roger Maris Cancer Center
  • Akron Children's HospitalRecruiting
  • Cincinnati Children's Hospital Medical Center
  • University Hospitals Cleveland Medical CenterRecruiting
  • Cleveland Clinic
  • Nationwide Children's Hospital
  • OU Medical Center Investigational Drug Pharmacy
  • University of Oklahoma Health Sciences Center
  • The Children's Hospital of PhiladelphiaRecruiting
  • St. Christopher's Hospital for Children
  • UPMC Children's Hospital of PittsburghRecruiting
  • Medical University of South Carolina: Investigational Drug ServicesRecruiting
  • Medical University of South Carolina: Shawn Jenkins Women's and Children's HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Monroe Carell Jr. Children's Hospital at VanderbiltRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Texas Children's Hospital- Main Hospital
  • Texas Children's Hospital- Wallace Tower
  • The Children's Hospital of San Antonio
  • University of Texas Health San Antonio
  • Primary Children's Hospital
  • Seattle Children's HospitalRecruiting
  • Children's Hospital of Wisconsin
  • Versiti Wisconsin
  • Kids Cancer CentreRecruiting
  • Prince of Wales HospitalRecruiting
  • The Royal Childrens Hospital
  • A.o.Landeskrankenhaus Innsbruck
  • Medizinische Universitaet Innsbruck
  • Medizinische Universitaet WienRecruiting
  • Kaye Edmonton Clinic
  • Stollery Children's Hospital
  • Hamilton Health Science Corporation/McMaster Children's HospitalRecruiting
  • The Hospital For Sick ChildrenRecruiting
  • CHU Sainte-Justine
  • Hopital de la Timone Enfants
  • CHRU de Montpellier - Hopital Arnaud de Villeneuve
  • Hopital Necker-Enfants maladesRecruiting
  • CHU de Bordeaux - Hopital Haut-Leveque
  • Service d'Imagerie Medicale du Pr F. Laurent
  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)Recruiting
  • Universitätsklinikum EssenRecruiting
  • Technische Universitat, Deutsches Herzzentrum MunchenRecruiting
  • Hadassah Medical Center (Ein Kerem)
  • O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde
  • Instituto Nacional De Cardiologia Ignacio Chavez
  • State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of
  • State Autonomous Healthcare Institution of Sverdlovsk Region
  • FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia
  • Hospital Sant Joan de DeuRecruiting
  • Hospital Universitario HM MonteprincipeRecruiting
  • Hospital Universitario Vall d´Hebron
  • Hospital Universitario La PazRecruiting
  • Adana Acibadem Hospital
  • Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD
  • Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's HospitalRecruiting
  • Ankara City Hospital Pediatric Hematology and Oncology Clinic
  • Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali
  • Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child
  • Dnipropetrovsk Regional Children's Hospital
  • Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"
  • Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"
  • Royal Hospital for ChildrenRecruiting
  • Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Cardiff & Vale NHS Health BoardRecruiting
  • Noah's Ark Children's Hospital for WalesRecruiting
  • Birmingham Children's Hospital NHS Foundation Trust
  • Birmingham Women's and Children's NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apixaban

Arm Description

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.

Outcomes

Primary Outcome Measures

The composite of major and clinically relevant non major bleeding.
The composite of major and clinically relevant non major bleeding.
A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.
A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.

Secondary Outcome Measures

Apixaban concentration
Apixaban concentration
Anti-Xa Levels
Anti-Xa Levels

Full Information

First Posted
May 26, 2015
Last Updated
February 6, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02464969
Brief Title
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2015 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Tablet or Solution
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
The composite of major and clinically relevant non major bleeding.
Description
The composite of major and clinically relevant non major bleeding.
Time Frame
up to 12 weeks
Title
A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.
Description
A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Apixaban concentration
Description
Apixaban concentration
Time Frame
Day 14
Title
Anti-Xa Levels
Description
Anti-Xa Levels
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 and are currently tolerating enteric medications, as per investigator's judgement. 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center http://www.bmsstudyconnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric Cardiology Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Loma Linda University Children's Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Children's Hospital and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Bass Speicalty Pharmacy
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Inpatient Pharmacy
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucile Packard Children's Hosptial - Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Loma Linda University Health Care
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UCSF Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Mission Bay Pediatric Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado - Investigational Drug Services
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Connecticut Children's Medical Center Pharmacy
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Nemours/ Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Terminated
Facility Name
JDCH Division of Pediatric Hematology and Oncology
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
AdventHealth Orlando-Pharmacy Investigational Drug Services
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
AdventHealth Pediatric Oncology Hematology at Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hematology and Oncology a division of Kidz medical Service
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Children's Healthcare of Atlanta-Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Bleeding and Clotting Disorders Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Unity Point Methodist Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
IU Health Pharmacy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York-Presbyterian Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Levine Children's Specialty Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Levine Children's Hospital, Pediatric Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Drug Service, Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Sanford Children's Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
OU Medical Center Investigational Drug Pharmacy
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina: Investigational Drug Services
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7610
Country
United States
Individual Site Status
Recruiting
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Children's Hospital- Main Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Children's Hospital- Wallace Tower
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Texas Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Versiti Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kids Cancer Centre
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Royal Childrens Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
A.o.Landeskrankenhaus Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Universitaet Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Kaye Edmonton Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Individual Site Status
Terminated
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Terminated
Facility Name
Hamilton Health Science Corporation/McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Hopital de la Timone Enfants
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHRU de Montpellier - Hopital Arnaud de Villeneuve
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Necker-Enfants malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux - Hopital Haut-Leveque
City
PESSAC Cedex
ZIP/Postal Code
33604
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'Imagerie Medicale du Pr F. Laurent
City
PESSAC Cedex
ZIP/Postal Code
33604
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Technische Universitat, Deutsches Herzzentrum Munchen
City
Munchen
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center (Ein Kerem)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Instituto Nacional De Cardiologia Ignacio Chavez
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of
City
Kazan
State/Province
Republic Tatarstan
ZIP/Postal Code
420138
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
State Autonomous Healthcare Institution of Sverdlovsk Region
City
Yekaterinburg
State/Province
Sverdlovsk Region
ZIP/Postal Code
620149
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Monteprincipe
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Adana Acibadem Hospital
City
Seyhan
State/Province
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD
City
Bahcelievler
State/Province
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital Pediatric Hematology and Oncology Clinic
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child
City
Dnipro
ZIP/Postal Code
49006
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Dnipropetrovsk Regional Children's Hospital
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Royal Hospital for Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Cardiff & Vale NHS Health Board
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Noah's Ark Children's Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Birmingham Children's Hospital NHS Foundation Trust
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Birmingham Women's and Children's NHS Foundation Trust
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B0661037
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Apixaban for the Acute Treatment of Venous Thromboembolism in Children

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