Study of CTS-1027 in Hepatitis C Patients

Exclusion Criteria

• •Decompensated or severe liver disease defined by one or more of the following criteria:
• •1. Prior liver biopsy showing cirrhosis
• •2. Prior liver biopsy showing bridging fibrosis (Metavir \>2 or Ishak \>3) more than 2 years ago in the absence of newer liver biopsy results
• •3. Prothrombin time: 3 seconds \> control
• •4. Total bilirubin \>= 1.5 x Upper limit of the normal range (ULN), or \> 3 x ULN for unconjugated bilirubin
• •5. Serum albumin below normal limits
• •6. AST or ALT \> 7 x ULN during baseline period
• •7. Evidence of portal hypertension including:
• •Splenomegaly or evidence of portal hypertension (i.e., enlarged portal vein and varices) on ultrasound,
• •Varices in esophagogastroduodenoscopy (EGD); or
• •Ascites
• •Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
• •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
• •Last baseline AST and ALT level prior to Day 1 of \< 1.5 x ULN
• •Renal impairment (creatinine \> 1.5 x ULN) or hepatorenal syndrome
• •Pancreatitis
• •Hospitalization for liver disease within 60 days of screening
• •Use of concomitant or prior drug therapy for HCV at screening, including the use of:
• •1. drugs with presumed anti-HCV activity in the prior three months
• •2. corticosteroids in the past 30 days
• •3. potentially hepatotoxic drugs in the past 30 days (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)
• •Use of illicit or drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
• •History of alcohol abuse within the past year
• •History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QT or 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.