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A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

This study has been completed.
Sponsor:
Collaborator:
Idun Pharmaceuticals
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00088140
First received: July 20, 2004
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Hepatitis C, Chronic
Drug: IDN-6556
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients

Resource links provided by NLM:


Further study details as provided by Conatus Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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

Enrollment: 204
Study Start Date: July 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088140

Locations
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
  More Information

No publications provided

Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00088140     History of Changes
Other Study ID Numbers: CL-000006556-PRO-0007
Study First Received: July 20, 2004
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014