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

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Hepatitis C, Chronic

Treatments

Drug: Placebo

Drug: PF-04136309

Study type

Interventional

Funder types

Industry

Identifiers

NCT01226797

A9421016

Details and patient eligibility

About

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

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).