Summary

Eligibility
for people ages up to 17 years (full criteria)
Location
at Oakland, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Kristin Shimano
Photo of Kristin Shimano
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

Eligibility

You can join if…

Open to people ages up to 17 years

  1. Birth to <18 years of age with a minimum weight of 2.6 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 6 to 12 weeks.
  4. Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding for at least 5 days.

You CAN'T join if...

  1. 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.
  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.
  12. . Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment.
  13. . Unable to take oral or enteric medication via the NG or G tube.
  14. . Known inherited or acquired antiphospholipid syndrome (APS).
  15. . Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)

Locations

  • Children's Hospital and Research Center Oakland in progress, not 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

Lead Scientist at UCSF

  • Kristin Shimano
    Associate Professor, Pediatrics. Authored (or co-authored) 26 research publications.

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