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

Last updated on June 19, 2019

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Study Location
Pfizer Investigational Site
Hong KOng, , 0 Hong Kong
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Hepatitis C
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Chronic HCV infection

- ALT >1.5 but

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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).

NCT01226797
Pfizer
Terminated
Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

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