Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation

Conatus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Liver Transplantation; Carcinoma, Hepatocellular; Hepatitis; Cholestasis

Treatments: Drug: IDN-6556; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080236

CL-000006556-PRO-0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 4 patient groups, including a placebo group

Donor organ placebo and Recipient placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo

Active Comparator group

Treatment:

Drug: Placebo

Drug: IDN-6556

Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg

Active Comparator group

Treatment:

Drug: IDN-6556

Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg

Active Comparator group

Treatment:

Drug: IDN-6556