Status:
COMPLETED
Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.
Eligibility Criteria
Inclusion
- Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
- HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL)
- Body Mass Index (BMI) of 18 to 35 kg/m², inclusive
Exclusion
- Women who are pregnant or breast feeding
- Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
- Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00971308
Start Date
October 1 2009
End Date
August 1 2010
Last Update
January 25 2011
Active Locations (6)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
3
Elite Research Institute
Miami, Florida, United States, 33169
4
Orlando Clinical Research Center
Orlando, Florida, United States, 32809