Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders

Inclusion Criteria

• Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial
• HCV genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, SOC) defined as:
• Failure to achieve an early virologic response ( 2 log decline at any time from Week 12 to Week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
• Decompensated or severe liver disease defined by one or more of the following criteria:
• Prothrombin time 3 seconds > control
• Direct bilirubin ≥ 1.5 x ULN
• Serum albumin below normal limits
• AST or ALT > 7 x ULN at screening
• Evidence of portal hypertension including:
• Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
• Ascites
• Cirrhosis defined by one or both of the following criteria:
• Liver biopsy showing cirrhosis
• Other clinical signs and symptoms suggestive of cirrhosis
• Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
• Clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
• Known history or presence of human immunodeficiency virus (HIV) infection
• Co-infection with hepatitis B virus (HBV)
• If female: pregnant, lactating, or positive serum or urine pregnancy test
• Male partners of women who are currently pregnant
• Renal impairment (creatinine > 1.5 x ULN), creatinine clearance 50 g per day) within the past year
• History of severe psychiatric disease, especially depression, characterized by:
• Suicide attempt
• Hospitalization for psychiatric disease
• Period of disability as a result of psychiatric disease
• Prior exposure to CTS-1027
• Prior triple treatment comprised of pegylated interferon, ribavirin, and protease and/or polymerase inhibitors
• History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QTc interval of > 450 milliseconds
• Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for ten or more years
• Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial.