A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Hepatitis C, Chronic Clinical Trial

Official title:

A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088140
• Other study ID #: CL-000006556-PRO-0007
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2004
• Last updated: August 9, 2012
• Start date: July 2004
• Est. completion date: October 2005

Study information

• Verified date: August 2012
• Source: Conatus Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• IDN-6556

• Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Conatus Pharmaceuticals Inc.	Idun Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
Primary	Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10