Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery
Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Protein Losing Enteropathy (PLE) is a serious medical condition that may develop in children
and adults with congenital heart disease for which a palliative procedure known as the
"Fontan procedure" has been performed. The loss of serum proteins into the gastrointestinal
tract that is associated with PLE can cause serious symptoms and life-threatening
complications. A number of clinical studies have suggested that heparin administration can
have clinical benefit in children with PLE, however the risk of bleeding associated with the
administration of heparin is an important concern and commonly limits its administration.
ODSH is a desulfated heparin with minimal anticoagulation properties but which, in
pre-clinical studies, appears to have the potential to replace heparin and greatly reduce the
risk of bleeding. This open label study is to assess the safety and evidence of therapeutic
effect of the administration of ODSH as a 4-day continuous intravenous infusion in patients
with an exacerbation of their PLE.