A RANDOMIZED OPEN-LABEL ACTIVE CONTROLLED SAFETY AND EXTRAPOLATED EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT
Investigating the Safety and Efficacy of Apixaban for Blood Clots in Children
Brief description of study.
The purpose of this research study is to assess the safety and efficacy of apixaban (which is a new anti-clotting drug) in the treatment of these blood clots in children.
Detailed description of study
The purpose of this study is to assess the safety and efficacy of apixaban in the treatment of these blood clots in children.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: VENOUS THROMBOEMBOLIC EVENT,blood clot,thromboembolism,pediatric,kid,kids,youth,adolescent,child,children,teen,teens,teenager,teenagers,riley
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Age: 12 years - 18 years
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Gender: All
Inclusion Criteria
Presence of an index VTE which is confirmed by imaging
Intention to manage the index VTE with anticoagulation treatment for at least 12 weeks or intention to manage the index VTE with anticoagulation treat in neonates for at least 6 weeks
Exclusion Criteria
Anticoagulant treatment for the index VTE for greater than 7 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 or conjugated bilirubin at randomization
At the time of randomization, inadequate renal function
At the time of randomization, uncontrolled severe hypertension
At the time of randomization, use of prohibited concomitant medication
Known allergy to apixaban
Female subject who are either pregnant or breastfeeding a child
Geographically unavailable for follow-up
This study investigates the safety and efficacy of an investigational medication for treating blood clots in children. Blood clots, also known as venous thromboembolism (VTE), can be serious and require careful management. The investigational medication is being studied to see how well it works and how safe it is for children with these conditions.
In this study, participants will receive either the investigational medication or a standard treatment. The procedures will involve regular monitoring and assessments to track the effectiveness and safety of the treatment. A placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine, may be used in some cases.
- Who can participate: Children with a confirmed blood clot (VTE) who are planned to receive anticoagulation treatment for at least 12 weeks, or 6 weeks for neonates, may participate. Participants should not have received more than 7 days of anticoagulant treatment before joining the study.
- Study details: Participants will be involved in receiving either the investigational medication or a standard treatment, which may include a placebo. They will undergo regular assessments to monitor the safety and effectiveness of the treatment.
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