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 : June 4, 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 28 days to <18 years will be dosed on a body weight tiered regimen. Subjects > or = 35 kg will receive 10 mg twice daily for 7 days followed by 5 mg twice daily thereafter;<35 kg to 25 kg will receive 8 mg twice daily for 7 days followed by 4 mg twice daily thereafter; <25 to 18 kg will receive 6 mg twice daily for 7 days and then 3mg twice daily thereafter; <18 to 12 kg will receive 4 mg twice daily for 7 days and then 2 mg twice daily thereafter; <12 to 9 kg will receive 3 mg twice daily for 7 days and then 1.5 mg twice daily thereafter; <9 kg to 6 kg will receive 2 mg twice daily for 7 days and 1 mg twice daily thereafter; <6 kg to 5 kg will receive 1 mg twice daily for 7 days and 0.5 mg twice daily thereafter; <5 kg to 4 kg will receive 0.6 mg twice daily for 7 days and 0.3 mg twice daily 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|