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

TerminatedPhase 2

Sponsor: Pfizer

Conditions: Hepatitis C, Chronic

Interventions: Placebo, PF-04136309

Countries: Hong Kong, India, Singapore, South Korea, Taiwan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).

Locations (10)

Prince of Wales Hospital, Shatin, New Territories,, Hong Kong, Hong Kong
Hong Kong, Hong Kong
Bangalore, Karnataka, India
Mumbai, Maharashtra, India
New Delhi, India
Singapore, Singapore
Seoul, South Korea
Seoul, South Korea
Kaohsiung City, Taiwan
Taipei, Taiwan