Summary

for people ages up to 17 years (full criteria)
at Oakland, California and other locations
study started
estimated completion:
Kristin Shimano

Description

Summary

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

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

Keywords

Venous Thromboembolism VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis Thromboembolism Apixaban Standard of Care

Eligibility

You can join if…

Open to people ages up to 17 years

  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.

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

  • Children's Hospital and Research Center Oakland accepting new patients
    Oakland California 94609 United States
  • UCSF Benioff Children's Hospital accepting new patients
    San Francisco California 94158 United States
  • UCSF Mission Bay Investigational Drug Pharmacy accepting new patients
    San Francisco California 94158 United States
  • UCSF Mission Bay Pediatric Clinical Research Center accepting new patients
    San Francisco California 94158 United States
  • Lucile Packard Children's Hospital - Stanford University accepting new patients
    Palo Alto California 94304 United States
  • Lucile Packard Children's Hosptial - Stanford University accepting new patients
    Palo Alto California 94304 United States

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
July 5, 2018