A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients

The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.

Inclusion Criteria:

• Chronic hepatitis C infection
• Unsuccessful prior HCV treatment
• Liver impairment (either AST or ALT 1.5-10.0 x ULN)
• Alpha-fetoprotein <= 50 ng/mL
• Adequate hematologic parameters

Exclusion Criteria:

• Decompensated or severe liver disease
• Hepatocellular carcinoma
• HIV infection
• Co-infection with hepatitis B virus (HBV)
• Renal impairment
• Pancreatitis
• Use of illicit or drugs of abuse
• History of alcohol abuse
• Presence of clinically significant cardiac arrhythmias
• If female, pregnant or lactating