A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype

1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).

• Drug: Peg-Intron
  
  SC injection, weight based dosing, weekly, 48 weeks
• Drug: REBETOL
  
  Capsules, weight based dosing, Q12 hrs daily, 48weeks
• Drug: HCV 796
  
  Capsules, 500 mg, Q 12 hrs. daily, 48 weeks

• Active Comparator: 1
  
  Interventions:
  

  • Drug: Peg-Intron
  • Drug: REBETOL
• Active Comparator: 2
  
  Interventions:
  

  • Drug: HCV 796
  • Drug: Peg-Intron
  • Drug: REBETOL
• Active Comparator: 3
  
  Interventions:
  

  • Drug: HCV 796
  • Drug: Peg-Intron
  • Drug: REBETOL

Inclusion Criteria:

• Infection with HCV genotype 1.
• HCV- infected subjects naive to treatment.
• HCV-infected non-responder subjects.

Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• ALT >/ or = 5X the upper limit of normal.
• AST >/ or = 5X the upper limit of normal.