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Status:

TERMINATED

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

Lead Sponsor:

Pfizer

Conditions:

Hepatitis C, Chronic

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

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

Detailed 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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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).

Key Trial Info

Start Date :

January 17 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 9 2012

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT01226797

Start Date

January 17 2011

End Date

February 9 2012

Last Update

July 27 2023

Active Locations (10)

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Page 1 of 3 (10 locations)

1

The Chinese University of Hong Kong,

Prince of Wales Hospital, Shatin, New Territories,, Hong Kong, Hong Kong, 0

2

The University of Hong Kong,

Hong Kong, Hong Kong, 0

3

Manipal Hospital

Bangalore, Karnataka, India, 560017

4

Seth G. S. Medical College & King Edward Memorial Hospital,

Mumbai, Maharashtra, India, 400 012