Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-04136309 500 MG BID IN SUBJECTS WITH CHRONIC HCV INFECTION AND RAISED AMINOTRANSFERASES

This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.

Study recruitment was stopped on Dec 15, 2011 due to difficulty in enrolling the targeted number of patients. Subjects currently enrolled into the study will complete the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The new anticipated Last Subject Last Visit (LSLV) is February 2012.

Inclusion Criteria:

• Chronic HCV infection
• ALT >1.5 but <10 times upper limit of normal

Exclusion Criteria:

• Decompensated or severe liver disease defined by one or more of the following criteria:

Prior liver biopsy showing cirrhosis.

• International Normalized Ratio (INR) greater than or equal to 1.5.
• Total bilirubin greater than or equal to 1.5X ULN, or >2X ULN for unconjugated bilirubin.
• Serum albumin below normal.
• ALT or aspartate aminotransferase (AST) >10 x ULN.
• Evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
• Presence of human immunodeficiency virus (HIV).
• Co-infection with hepatitis B virus (HBV).
• Co-infection with Epstein Barr Virus (EBV) and/or Cytomegalovirus (CMV).