Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Status: Recruiting
Phase:
DFCI Protocol ID:

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

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Cameron Trenor, MD, Children's Hospital Boston

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.

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