Apixaban for the Acute Treatment of Venous Thromboembolism in Children
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|ClinicalTrials.gov Identifier: NCT02464969|
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: Apixaban Drug: Standard of Care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 22, 2015|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
Subjects between birth to <18 years will be dosed on a body weight tiered regimen. Subjects ≥35kg will receive 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg will receive 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg will receive 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg will receive 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg will receive 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg will receive 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg will receive 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg will receive 0.6mg twice daily for 7 days and 0.3mg BID thereafter;PK cohort neonates ≥ 2.6kg will receive 0.1mg BID. Dose will be adjusted as determined by PK measurements (ie, to 0.2mg BID, 0.1mg daily or dose will stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis,subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter.
Tablet or Solution
Active Comparator: Standard of Care
Subjects will receive a dose and dosing regimen of anticoagulation treatment based on usual and customary care per local practices.
Drug: Standard of Care
Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.
- The composite of major and clinically relevant non major bleeding. [ Time Frame: up to 12 weeks ]The composite of major and clinically relevant non major bleeding.
- A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality. [ Time Frame: up to 12 weeks ]A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.
- Apixaban concentration [ Time Frame: Day 14 ]Apixaban concentration
- Anti-Xa Levels [ Time Frame: Day 14 ]Anti-Xa Levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464969
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|