Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Completed · Phase 4

Conditions studied: Venous Thromboembolism

In brief

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

Key facts

Study ID

NCT02464969

Run by

Bristol-Myers Squibb

People needed

229

Starts

2015-11-22

Expected to finish

2024-04-30

Last updated by the study team

2024-10-29

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Loma Linda University Children's Hospital — Loma Linda, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Valley Children's Hospital — Madera, California, United States
• Children's Hospital and Research Center Oakland — Oakland, California, United States
• Bass Speicalty Pharmacy — Palo Alto, California, United States
• Inpatient Pharmacy — Palo Alto, California, United States
• Lucile Packard Children's Hosptial - Stanford University — Palo Alto, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Loma Linda University Health Care — San Bernardino, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• UCSF Mission Bay Pediatric Clinical Research Center — San Francisco, California, United States
• Children's Hospital Colorado - Investigational Drug Services — Aurora, Colorado, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Connecticut Children's Medical Center Pharmacy — Hartford, Connecticut, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Nemours/ Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• JDCH Division of Pediatric Hematology and Oncology — Hollywood, Florida, United States
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Pediatric Cardiology Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.