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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-17

Study Completion Date

2012-02-09

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

PF-04136309

Group Type ACTIVE_COMPARATOR

PF-04136309

Intervention Type DRUG

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Interventions

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Placebo

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Intervention Type DRUG

PF-04136309

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No