Overview

A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Conatus Pharmaceuticals Inc.
Collaborator:
Idun Pharmaceuticals
Treatments:
Caspase Inhibitors
Criteria
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