A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
1 other identifier
interventional
204
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 20, 2004
CompletedFirst Posted
Study publicly available on registry
July 21, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedAugust 13, 2012
August 1, 2012
1.3 years
July 20, 2004
August 9, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (4)
Placebo
PLACEBO COMPARATORIDN-6556 5 mg twice a day (BID)
ACTIVE COMPARATORIDN-6556 25mg twice a day (BID)
ACTIVE COMPARATORIDN-6556 50 mg twice a day (BID)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Conatus Pharmaceuticals Inc.lead
- Idun Pharmaceuticalscollaborator
Study Sites (15)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Scripps Clinic
La Jolla, California, 92067, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33136, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
The Mayo Clinic
Rochester, Minnesota, 55905, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27715, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Metrohealth Medical Center
Cleveland, Ohio, 44109, United States
Medical College of Virginia
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2004
First Posted
July 21, 2004
Study Start
July 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
August 13, 2012
Record last verified: 2012-08