Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

Completed · Phase 1

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT00971308

Run by

Bristol-Myers Squibb

People needed

37

Starts

2009-10-01

Expected to finish

2010-08-01

Last updated by the study team

2011-01-25

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Research Institute — Anaheim, California, United States
• West Coast Clinical Trials, Llc — Cypress, California, United States
• Elite Research Institute — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Parexel International - Baltimore Epcu — Baltimore, Maryland, United States
• Alamo Medical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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