Status:
COMPLETED
A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
Lead Sponsor:
Conatus Pharmaceuticals Inc.
Collaborating Sponsors:
Idun Pharmaceuticals
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00088140
Start Date
July 1 2004
End Date
October 1 2005
Last Update
August 13 2012
Active Locations (15)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Scripps Clinic
La Jolla, California, United States, 92067
3
California Pacific Medical Center
San Francisco, California, United States, 94115
4
University of California, San Francisco
San Francisco, California, United States, 94143