logo Hematology/Oncology Research Studies: Open for Enrollment Date: 01/26/21


Randomized, open-label, active controlled, safety and extrapolated efficacy study in pediatric subjects requiring anticoagulation for treatment of a venous thromboembolic event

NCT#/Phase: NCT02464969
Phase 4
IRB#: 2015-063
Description: This study tests safety and efficacy of the drug Apixaban in children with a venous thromboembolic event. Apixaban is an oral direct inhibitor of Factor Xa that was shown in large studies in adults to be an efficacious alternative to current standards of care. It interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Apixaban is given orally twice a day and does not require regular monitoring with blood tests. The study is a 2:1 randomization between Apixaban and continuation of the standard treatment, performed within the first 7 days from imitation of treatment. Those who are randomized to Apixaban arm will receive the drug for 12 weeks with options for continuation. Primary objective: To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE. Secondary objective: To evaluate apixaban pharmacokinetic (PK) and anti-FXa activity in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Inclusion: Children between 3 months to less than 18 years of age at the time of consent who have developed a new clot which needs treatment with anticoagulants.
Enrollment Status: Open for enrollment
Sponsor: Pfizer
Principal Investigator(s): Titi Singer, MD
Contact(s): Sheila Contapay-Tabilin, RN (510-428-3885 x4754)
Lisa Du (510-428-3885 x2513)
Study Link: https://clinicaltrials.gov/ct2/show/NCT02464969

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000