A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Phase 2

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Placebo; Drug: IDN-6556

• Registration Number: NCT00088140
• Lead Sponsor: Conatus Pharmaceuticals Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-07-20
• Study First Submitted QC: 2004-07-20
• Study First Posted: 2004-07-21
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-09
• Last Update Posted: 2012-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
IDN-6556 25mg twice a day (BID)	IDN-6556	-
IDN-6556 5 mg twice a day (BID)	IDN-6556	-
IDN-6556 50 mg twice a day (BID)	IDN-6556	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Metrohealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Mt. Sinai School of Medicine; 🇺🇸 New York City, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States

Beth Israel Deaconness Medical Center; 🇺🇸 Boston, Massachusetts, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Medical College of Virginia; 🇺🇸 Richmond, Virginia, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

The Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States