Apixaban for the Acute Treatment of Venous Thromboembolism in Children

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    250
  • sponsor
    Pfizer
Updated on 23 November 2020
Investigator
Pfizer CT.gov Call Center
Primary Contact
Childrens National Medical Center (5.4 mi away) Contact
+160 other location
heparin
vitamin k antagonist
vitamin k
venous thromboembolism
apixaban
anticoagulation therapy

Summary

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

Details
Treatment Standard of Care, Apixaban
Clinical Study IdentifierNCT02464969
SponsorPfizer
Last Modified on23 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 17 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thromboembolism or Thromboembolism?
Do you have any of these conditions: Thromboembolism or Venous Thromboembolism?
Do you have any of these conditions: Venous Thromboembolism or Thromboembolism?
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 for at least 5 days

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 <50109 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.)
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