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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

Recruiting
12-18 years
All
Phase N/A

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.
Study details
    VENOUS THROMBOEMBOLIC EVENT
    blood clot
    thromboembolism
    pediatric
    kid
    kids
    youth
    adolescent
    child
    children
    teen
    teens
    teenager
    teenagers
    riley

TX6717

19 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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