A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088140
Recruitment Status : Completed
First Posted : July 21, 2004
Last Update Posted : August 13, 2012
Idun Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: IDN-6556 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
Study Start Date : July 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: IDN-6556 5 mg twice a day (BID) Drug: IDN-6556
Active Comparator: IDN-6556 25mg twice a day (BID) Drug: IDN-6556
Active Comparator: IDN-6556 50 mg twice a day (BID) Drug: IDN-6556

Primary Outcome Measures :
  1. Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
  2. Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088140

United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
Scripps Clinic
La Jolla, California, United States, 92067
California Pacific Medical Center
San Francisco, California, United States, 94115
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Mt. Sinai School of Medicine
New York City, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27715
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Idun Pharmaceuticals

Responsible Party: Conatus Pharmaceuticals Inc. Identifier: NCT00088140     History of Changes
Other Study ID Numbers: CL-000006556-PRO-0007
First Posted: July 21, 2004    Key Record Dates
Last Update Posted: August 13, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Caspase Inhibitors
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action