Apixaban for the Acute Treatment of Venous Thromboembolism in Children

NCT02464969

Last updated date
Study Location
The Children's Hospital at Montefiore
Bronx, New York, 10467, United States

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-17
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 for at least 5 days.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Apixaban for the Acute Treatment of Venous Thromboembolism in Children
Official Title  ICMJE A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT
Brief Summary To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Apixaban
  • Active Comparator: Standard of Care
    Subjects will receive a dose and dosing regimen of anticoagulation treatment based on usual and customary care per local practices.
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
250
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2015)
150
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 for at least 5 days.

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Germany,   Israel,   Portugal,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02464969
Other Study ID Numbers  ICMJE B0661037
2014-002606-20 ( EudraCT Number )
CV185-325 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP