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Apixaban for the Acute Treatment of Venous Thromboembolism in Children
Overall Recruitment Status: Active, currently enrolling
 
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
 
Region Sponsors
California - Northern
Pfizer
 
Acronym KP IRB No.
1318967
 
Study Type Phase
Clinical Trial Phase IV
 
Study Population Description
Children requiring anticoagulation for the treatment of a venous thromboembolism (VTE).
 
Purpose
The purpose of this study is to assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a Venous Thromboembolic Event (VTE).
 
Detailed Description
The primary study objective is to assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE. The secondary objective is to evaluate apixaban pharmacokinetic (PK) and anti-FXa activity in pediatric subjects requiring anticoagulation for the treatment of a VTE. Treatment assignment will not be blinded. Approximately 150 subjects will be randomized into the trial using a ratio of 2 to 1 to apixaban or standard of care (SOC), respectively. Subjects may receive up to 7 days of standard anticoagulant treatment prior to randomization. Subjects will be monitored for laboratory safety parameters. Pre- and post-dose blood samples for peak and trough apixaban concentrations (PK) and anti-FXa activity levels (PD) will be obtained. In addition to the radiologic images obtained to confirm the index event, new radiologic images of the clot will be obtained at approximately the mid-point and end of treatment (EOT) visits. In addition, when medically appropriate, new radiologic images will be obtained if recurrent VTE is suspected. Palatability of the apixaban oral solution and apixaban 0.5-mg tablet will be assessed.
 
Gender Age Limit
Male & Female 3 months - 17 years
 
Inclusion Criteria
  • 3 months to <18 years of age with a minimum weight of 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 12 weeks.
 
Exclusion Criteria
  • Anticoagulant treatment for the index VTE for greater than 7 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.

 
Keywords and/or Specific Medical Conditions
  • Thromboembolism
  • Hematology
  • Anticoagulants
  • Molecular Mechanisms of Pharmacological Action
  • Antithrombins
  • Oncology (Pediatrics)
  • Apixaban
  • Pediatrics
  • Apixaban
  • Protease Inhibitors
  • Cardiovascular Diseases
  • Serine Proteinase Inhibitors
  • Eliquis
  • Thrombosis
  • Embolism
  • Vascular Diseases
  • Embolism and Thrombosis
  • Venous Thromboembolism
  • Enzyme Inhibitors
  • VTE
  • Factor Xa Inhibitors
 
KP Clinical Facility
  • Oakland Medical Center
  • Roseville Medical Center
 
Clinical Area
  • Hematology
  • Oncology (Pediatrics)
  • Pediatrics


Principal Investigator:
Sonali Lakshminarayanan
Contact Information:
- Tashia Orr
-tashia.orr@kp.org
-Roseville Medical Center
- Isabella Hamilton
-isabella.c.hamilton@kp.org
-Oakland Medical Center


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