A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C

In brief

The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

Key facts

Study ID: NCT00663208
Run by: Bristol-Myers Squibb
People needed: 167
Starts: 2008-05-01
Expected to finish: 2009-06-01
Last updated by the study team: 2015-10-14

Who can join

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

You may qualify if…

Chronically infected with Hepatitis C Virus (HCV) genotype 1
Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or Hepatitis B Virus
HCV RNA viral load of ≥10*5 IU/mL
BMI 18 to 35kg/m²

You may not qualify if…

Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with Hepatitis C Virus infection
HIV and/or HBV positive
Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
WOCBP will be enrolled as in-patient for 16 days

Where it is running

Advanced Clinical Res Inst — Anaheim, California, United States
West Coast Clinical Trials, Llc — Cypress, California, United States
Yale University School of Medicine — New Haven, Connecticut, United States
Elite Research Institute — Miami, Florida, United States
Orlando Clinical Research Center — Orlando, Florida, United States
Parexel International Corporation — Baltimore, Maryland, United States
Alamo Medical Research — San Antonio, Texas, United States
Local Institution — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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