drugset / Trial / NCT00812370

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.

Timeline

Start
2008-09
Primary completion
2013-01
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalirudin Peptide 0.125 mg/kg