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

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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).