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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

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ClinicalTrials.gov Identifier: NCT02464969
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : October 3, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 29, 2021
Estimated Study Completion Date : April 29, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Apixaban
Subjects between 3 month 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.
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.




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



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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. 3 months to <18 years of age with a minimum weight of 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 12 weeks.

Exclusion Criteria:

  1. Anticoagulant treatment for the index VTE for greater than 7 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.

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

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Sponsors and Collaborators
Pfizer
Bristol-Myers Squibb
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02464969     History of Changes
Other Study ID Numbers: B0661037
2014-002606-20 ( EudraCT Number )
BMS STUDY NUMBER CV185-325 ( Other Identifier: Alias Study Number )
CV185-325 ( Other Identifier: Alias Study Number )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Keywords provided by Pfizer:
VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis

Additional relevant MeSH terms:
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