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Eligibility
for people ages up to 17 years
Location
at Oakland, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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

Official Title

A Randomized, Open-label, Active Controlled, Safety And Extrapolated Efficacy Study In Pediatric Subjects Requiring Anticoagulation For The Treatment Of A Venous Thromboembolic Event

Keywords

Venous Thromboembolism VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis Apixaban

Eligibility

You can join if…

Open to people ages up to 17 years

  1. 12 to <18 years of age at the time of consent.
  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.

You CAN'T join if...

  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.

Locations

  • Lucile Packard Children's Hospital - Stanford University accepting new patients
    Palo Alto, California, 94304, USA
  • Lucile Packard Children's Hosptial - Stanford University accepting new patients
    Palo Alto, California, 94304, USA
  • Loma Linda University Children's Hospital not yet accepting patients
    Loma Linda, California, 92354, USA
  • Loma Linda University Clinical Trial Center not yet accepting patients
    Loma Linda, California, 92354, USA
  • Loma Linda University Investigational Drug Pharmacy not yet accepting patients
    Loma Linda, California, 92354, USA
  • Pediatric Specialty Team Centers of LLUCH not yet accepting patients
    Loma Linda, California, 92354, USA
  • LLU Pediatric Hematology and Oncology Clinic not yet accepting patients
    San Bernardino, California, 92408, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02464969
Phase
Phase 4
Lead Scientist
Kristin Shimano
Study Type
Interventional
Last Updated
April 2017
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