A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
NCT ID: NCT00088140
Last Updated: 2012-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2004-07-31
2005-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
IDN-6556 5 mg twice a day (BID)
IDN-6556
IDN-6556 25mg twice a day (BID)
IDN-6556
IDN-6556 50 mg twice a day (BID)
IDN-6556
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IDN-6556
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Idun Pharmaceuticals
INDUSTRY
Conatus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Hospital
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
The Mayo Clinic
Rochester, Minnesota, United States
Mt. Sinai School of Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Medical College of Virginia
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL-000006556-PRO-0007
Identifier Type: -
Identifier Source: org_study_id