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A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

Trial Profile

A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 04 Jan 2024

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At a glance

  • Drugs Apixaban (Primary) ; Heparin; Low molecular weight heparins; Vitamin K antagonists
  • Indications Venous thromboembolism
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Bristol-Myers Squibb; Pfizer
  • Most Recent Events

    • 19 Dec 2022 Planned End Date changed from 30 Apr 2023 to 30 Apr 2024.
    • 19 Dec 2022 Planned primary completion date changed from 30 Apr 2023 to 30 Apr 2024.
    • 18 Jun 2020 Treatments section is updated to include one more dose range for an additional body weight window as- greater than or equal to 2.6kg will receive 0.1mg BID, and also PK sub-analysis part is introduced into the treatment with 2 new dose ranges as- "PK sub analysis, subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter". Eligibility criteria is updated to include minimum subject age as- new-born and minimum weight as 2.6 Kg instead of 28 days and 4 Kg respectively.
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