Status:
COMPLETED
A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00663208
Start Date
May 1 2008
End Date
June 1 2009
Last Update
October 14 2015
Active Locations (8)
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1
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
2
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
4
Elite Research Institute
Miami, Florida, United States, 33169