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Summary

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

Conditions

Venous Thromboembolism

Recruitment Status

Recruiting

Eligibility Criteria

Inclusion Criteria:

Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization.
Presence of an index VTE which is confirmed by imaging.
Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks.
Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator's judgement.

Exclusion Criteria:

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.
Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE.
A mechanical heart valve.
Active bleeding or high risk of bleeding at the time of randomization.
Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.
Abnormal baseline liver function at randomization.
Inadequate renal function at the time of randomization.
Platelet count <50×109 per L at randomization.
Uncontrolled severe hypertension at the time of randomization.
Use of prohibited concomitant medication at the time of randomization.
Female subjects who are either pregnant or breastfeeding a child.
Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment.
Unable to take oral or enteric medication via the NG or G tube.
Known inherited or acquired antiphospholipid syndrome (APS).
Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)

Intervention

Intervention Type

Intervention Name

Drug

Apixaban

Drug

Standard of Care

Phase

Phase 4

Gender

All

Min Age

0 Days

Max Age

17 Years

Download Date

February 8, 2023

Principal Investigator

N/A

Primary Contact Information

BMS Study Connect Contact Center http://www.bmsstudyconnect.com

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT# and Site #.

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Apixaban for the Acute Treatment of Venous Thromboembolism in Children NCT02464969 BMS Study Connect Contact Center http://www.bmsstudyconnect.com 855-907-3286 Clinical.Trials@bms.com First line of the email MUST contain NCT# and Site #.