A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Conatus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Placebo; Drug: IDN-6556

Study type: Interventional

Funder types: Industry

Identifiers

NCT00088140

CL-000006556-PRO-0007

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

IDN-6556 5 mg twice a day (BID)

Active Comparator group

Treatment:

Drug: IDN-6556

IDN-6556 25mg twice a day (BID)

Active Comparator group

Treatment:

Drug: IDN-6556

IDN-6556 50 mg twice a day (BID)

Active Comparator group

Treatment:

Drug: IDN-6556