Carcinoma, Hepatocellular, Cholestasis, Hepatitis, Liver Transplantation
Conditions
Keywords
Liver Transplantation
Brief summary
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
Detailed description
The occurrence of apoptosis in liver ischemia/reperfusion injury has been well characterized in animal models. In this context apoptosis has specifically been observed in sinusoidal endothelial cells and hepatocytes, and this has also been associated with an increase in activated caspase-3 in liver tissue extracts. The use of caspase inhibitors to prevent apoptosis during liver storage and transplantation may reduce ischemia/reperfusion injury and hence improve graft function after transplantation. Suppression of apoptosis by caspase inhibitors may also allow for longer ischemic times allowing organs to be transported greater distances. In addition, suppression of apoptosis may lower the risk involved in using suboptimal donor organs.
Interventions
DRUGIDN-6556
DRUGPlacebo
Sponsors
Idun Pharmaceuticals
Conatus Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum adult age
Exclusion criteria
* Fulminant hepatic failure (UNOS Status I patients) * Previous liver transplantation * Patients undergoing split liver grafts * Extrahepatic malignancy * If female, pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation | — |
| Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation | — |
Countries
Germany, United States
Outcome results
None listed