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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02464969
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Apixaban Drug: Standard of Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT
Actual Study Start Date : November 22, 2015
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Apixaban
Subjects between 28 days to <18 years will be dosed on a body weight tiered regimen. Subjects > or = 35 kg will receive 10 mg twice daily for 7 days followed by 5 mg twice daily thereafter;<35 kg to 25 kg will receive 8 mg twice daily for 7 days followed by 4 mg twice daily thereafter; <25 to 18 kg will receive 6 mg twice daily for 7 days and then 3mg twice daily thereafter; <18 to 12 kg will receive 4 mg twice daily for 7 days and then 2 mg twice daily thereafter; <12 to 9 kg will receive 3 mg twice daily for 7 days and then 1.5 mg twice daily thereafter; <9 kg to 6 kg will receive 2 mg twice daily for 7 days and 1 mg twice daily thereafter; <6 kg to 5 kg will receive 1 mg twice daily for 7 days and 0.5 mg twice daily thereafter; <5 kg to 4 kg will receive 0.6 mg twice daily for 7 days and 0.3 mg twice daily thereafter.
Drug: Apixaban
Tablet or Solution

Active Comparator: Standard of Care
Subjects will receive a dose and dosing regimen of anticoagulation treatment based on usual and customary care per local practices.
Drug: Standard of Care
Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.




Primary Outcome Measures :
  1. The composite of major and clinically relevant non major bleeding. [ Time Frame: up to 12 weeks ]
    The composite of major and clinically relevant non major bleeding.

  2. A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality. [ Time Frame: up to 12 weeks ]
    A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.


Secondary Outcome Measures :
  1. Apixaban concentration [ Time Frame: Day 14 ]
    Apixaban concentration

  2. Anti-Xa Levels [ Time Frame: Day 14 ]
    Anti-Xa Levels



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 28 days to <18 years of age with a minimum weight of 4 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.
  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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464969


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

Locations
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Sponsors and Collaborators
Pfizer
Bristol-Myers Squibb
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02464969    
Other Study ID Numbers: B0661037
2014-002606-20 ( EudraCT Number )
CV185-325 ( Other Identifier: Alias Study Number )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants