Summary

for people ages 3 months 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 ThromboembolismVTE, thromboembolism, thrombosis, embolism, apixaban, EliquisThromboembolismApixabanStandard of Care

Eligibility

You can join if…

Open to people ages 3 months 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 Oaklandaccepting new patients
    OaklandCalifornia94609United States
  • UCSF Benioff Children's Hospitalaccepting new patients
    San FranciscoCalifornia94158United States
  • UCSF Mission Bay Investigational Drug Pharmacyaccepting new patients
    San FranciscoCalifornia94158United States
  • UCSF Mission Bay Pediatric Clinical Research Centeraccepting new patients
    San FranciscoCalifornia94158United States

Lead Scientist

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
Study Type
Interventional
Last Updated