A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Conatus Pharmaceuticals Inc.204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

204

Conditions

Hepatitis C, Chronic

Interventions

IDN-6556DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Mayo Clinic Hospital

Phoenix, Arizona, United States

Scripps Clinic

La Jolla, California, United States

California Pacific Medical Center

Outcomes

Primary Outcomes

Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10

Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10

Data from ClinicalTrials.gov

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