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Hepatitis A |
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Clinical Trial: A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
This study is currently recruiting patients.
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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
Expected Total Enrollment: 200
Study start: July 2004; Expected 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:
- 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
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
Paul Pockros, MD, Principal Investigator
California Pacific Medical Center, San Francisco, California, 94115, United States; Recruiting
Anna von Bakonyi, LVN 415-600-1107 VonbakA@sutterhealth.org
Robert Gish, MD, Principal Investigator
Robert Gish, MD, Principal Investigator
University of California, San Francisco, San Francisco, California, 94143, United States; Recruiting
Melissa Hinds 415-502-8612 gastm@itsa.ucsf.edu
Norah Terrault, MD, MPH, Principal Investigator
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
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
Paul Kwo, MD, Principal Investigator
Massachusetts
Beth Israel Deaconness Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Mohammed Zaman, MD 617-632-1067 mzaman1@caregroup.harvard.edu
Nezam Afdhal, MD, Principal Investigator
Nezam Afdhal, MD, Principal Investigator
New York
Mt. Sinai School of Medicine, New York City, New York, 10029, United States; Recruiting
Jenny Figueroa, RN, BSN 212-659-8053 jennie.figueroa@msnyuhealth.org
Efesvia Albanis, MD, Principal Investigator
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
John McHutchison, MD, Principal Investigator
Andrew Muir, MD, Principal Investigator
University of North Carolina, Chapel Hill, North Carolina, 27599, United States; Recruiting
Linda Anderson, RN 919-843-0691 linda_anderson@med.unc.edu
Michael Fried, MD, Principal Investigator
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
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
Mitchell Shiffman, MD, Principal Investigator
More Information
Study ID Numbers: CL-000006556-PRO-0007
Record last reviewed: January 2005
Last Updated: January 13, 2005
Record first received: July 20, 2004
ClinicalTrials.gov Identifier: NCT00088140
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: January 2005
Last Updated: January 13, 2005
Record first received: July 20, 2004
ClinicalTrials.gov Identifier: NCT00088140
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- American Liver Foundation
- Cause of Hepatitis A Virulence Pinpointed (National Institute of Allergy and Infectious Diseases)
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