Pfizer Pediatric VTE Treatment study
Research type
Research Study
Full title
A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT
IRAS ID
225240
Contact name
Jayashree Motwani
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-002606-20
Clinicaltrials.gov Identifier
66,106, IND
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
This study will include participants that have a venous thromboembolic event (VTE) which means that there is a blood clot in either the upper leg (deep vein thrombosis [DVT]), and/or lung (pulmonary embolism [PE]), or another place in the body.
Apixaban (anti-clotting drug) is currently approved to treat blood clots in adults.This study will look at the safety and efficiency of Apixaban for the treatment of these blood clots in children.
There will be around 150 participants in this study in roughly 25 sites in 4 countries. The aim is to have 30 or more participants enrolled into each of the 4 age groups - 12-18, 2-12, 29 days to 2, and neonates
Participants will received either standard of care treatment or Apixaban and remain in the study for 12 weeks which will include 5 visits to the research site.
Apixaban will be supplied either as a tablet or as an oral solution depending on each participants age, weight and his/her ability to swallow tablets.Lay summary of study results: https://www.bms.com/assets/bms/shared/plain-language-summary/cv185-325/cv185-325-pls-en-final-approved.pdf
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
17/WM/0282
Date of REC Opinion
31 Aug 2017
REC opinion
Further Information Favourable Opinion