The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin. The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
capsule, oral, 4 doses once daily or twice daily, 3 days
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
subcutaneous injection, 180 μg, once weekly, 48 weeks
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States
Henry Ford Health Sytem
Detroit, Michigan, United States
The liver institute at Methodist hospital
Dallas, Texas, United States
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)
Time frame: Daily for the first 3 days and at each study visit
To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)
Time frame: Week 4 and Week 12
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)
Time frame: Study visits throughout part B
To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)
Time frame: Study visits throughout Part A
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)
Time frame: Time points through Part B
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tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
Alamo Medical Research
San Antonio, Texas, United States
ACLIRES Argentina SRL
Buenos Aires, Argentina
Hospital Universitario Austral
Buenos Aires, Argentina
Downtown ID Clinic/University of British Columbia
Vancouver, British Columbia, Canada
John Buhler Research Centre
Winnipeg, Manitoba, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Fundacion de Investigation de Diego
Santurce, Puerto Rico