A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

August 9, 2012 updated by: Conatus Pharmaceuticals Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conatus Pharmaceuticals Inc.

Collaborators

Idun Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

July 20, 2004

First Submitted That Met QC Criteria

July 20, 2004

First Posted (Estimate)

July 21, 2004

Study Record Updates

Last Update Posted (Estimate)

August 13, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-000006556-PRO-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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