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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00080236
• Date of registration: 24/03/2004
• Prospective Registration: No
• Primary sponsor: Conatus Pharmaceuticals Inc.
• Public title: Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
• Scientific title: Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
• Date of first enrolment: November 2003
• Target sample size: 99
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00080236
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cholestasis

Hepatitis

Carcinoma, Hepatocellular

Liver Transplantation

Intervention(s)

Drug: IDN-6556

Drug: Placebo

Primary Outcome(s)

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

Secondary ID(s)

CL-000006556-PRO-0006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Idun Pharmaceuticals