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A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

This study is currently recruiting patients.

Sponsored by: Idun Pharmaceuticals
Information provided by: Idun Pharmaceuticals

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 Treatment or Intervention Phase
Hepatitis C, Chronic
  Drug: IDN-6556
 Phase II

MedlinePlus related topics:  Hepatitis;   Hepatitis C

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

Primary Outcomes: transamininase changes

Expected Total Enrollment:  200

Study start: July 2004;  Study completion: May 2005
Last follow-up: March 2005;  Data entry closure: May 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information


California
      Scripps Clinic, La Jolla,  California,  92067,  United States; Recruiting
Lee Goodman, RN  858-554-6822    legoodman@scrippsclinic.com 
Paul Pockros, MD,  Principal Investigator

      California Pacific Medical Center, San Francisco,  California,  94115,  United States; Recruiting
Leslie Taylor  415-600-1109    TaylorLL@sutterhealth.org 
Robert Gish, MD,  Principal Investigator

      University of California, San Francisco, San Francisco,  California,  94143,  United States; Recruiting
Wendy May Real  415-514-2861    wreal@itsa.ucsf.edu 
Norah Terrault, MD, MPH,  Principal Investigator

Florida
      University of Miami, Miami,  Florida,  33136,  United States; Recruiting
Heather Raley, RN, BSN  305-243-2148    hraley@med.miami.edu 
Eugene Schiff, MD,  Principal Investigator

Indiana
      Indiana University School of Medicine, Indianapolis,  Indiana,  46202,  United States; Recruiting
Virginia Blevins, RN  317-274-2701    vblevins@iupui.edu 
Paul Kwo, MD,  Principal Investigator

Massachusetts
      Beth Israel Deaconness Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Chelsea Macfarlane, RN, PhD  617-632-9716    cmacfarl@caregroup.harvard.edu 
Nezam Afdhal, MD,  Principal Investigator

Missouri
      St. Louis University School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
Cherryl Korte, RN  314-972-9394    KorteCL@slu.edu 
Adrian Di Bisceglie, MD,  Principal Investigator

New York
      Mt. Sinai School of Medicine, New York City,  New York,  10029,  United States; Recruiting
Rosemarie Gagliardi, PhD  212-659-8050    Rosemarie.gagliardi@msnyuhealth.org 
Efesvia Albanis, MD,  Principal Investigator

North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27715,  United States; Recruiting
Patricia Bixby, RN  919-681-6819    bixby001@mc.duke.edu 
John McHutchison, MD,  Principal Investigator
Andrew Muir, MD,  Principal Investigator

      University of North Carolina, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Susan Pusek  919-966-0128    suspusek@med.unc.edu 
Michael Fried, MD,  Principal Investigator

Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45267,  United States; Recruiting
Susan Sibert, RN  513-584-2363    susan.sibert@uc.edu 
Guy Neff, MD,  Principal Investigator

Virginia
      Medical College of Virginia, Richmond,  Virginia,  23298,  United States; Recruiting
Denice Shelton, RN  804-675-5000  Ext. 3686    denice.shelton@med.va.gov 
Mitchell Shiffman, MD,  Principal Investigator

More Information

Study ID Numbers:  CL-000006556-PRO-0007
Record last reviewed:  July 2004
Record first received:  July 20, 2004
ClinicalTrials.gov Identifier:  NCT00088140
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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