A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00088140

Run by

Conatus Pharmaceuticals Inc.

People needed

204

Starts

2004-07-01

Expected to finish

2005-10-01

Last updated by the study team

2012-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Scripps Clinic — La Jolla, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• The Mayo Clinic — Rochester, Minnesota, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Metrohealth Medical Center — Cleveland, Ohio, United States
• Medical College of Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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