The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Thrombosis is a significant medical complication in children with chronic diseases. The
currently utilized treatments have many drawbacks which can lead to poor outcomes. More
modern therapies are available but have not been systematically tested in children. This
study will determine whether one such medication, bivalirudin is a safer and more effective
alterative.
This study will monitor what effects the drug has upon the child's body and how the body
processes the study drug (absorption, metabolism and elimination). The study will also
evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The
safety issues being monitored relate to any observations of major or minor bleeding episodes
after taking the drug, and/or any other side effects.
Phase:
Phase 1
Details
Lead Sponsor:
Children's Hospital Los Angeles
Collaborators:
Baylor College of Medicine Children's Hospital Colorado Children's Hospital of Philadelphia Nationwide Children's Hospital Texas Children's Hospital University of Texas Southwestern Medical Center