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

Phase 2

• Conditions: Health Condition 1: null- Hepatitis C, Chronic

• Registration Number: CTRI/2011/04/001705
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

1.Chronic HCV infection

2.ALT lessthen 1.5 but greaterthen 10 times upper limit of normal

Exclusion Criteria

Decompensated or severe liver disease defined by one or more of the following criteria:

1.Prior liver biopsy showing cirrhosis.

2.International Normalized Ratio (INR) greater than or equal to 1.5.

3.Total bilirubin greater than or equal to 1.5X ULN, or greaterthen 2X ULN for unconjugated bilirubin.

4.Serum albumin below normal.

5.ALT or aspartate aminotransferase (AST) greaterthen 10 x ULN.

6.Evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.

7.Presence of human immunodeficiency virus (HIV).

8.Co-infection with hepatitis B virus (HBV).

9.Co-infection with Epstein Barr Virus (EBV) and/or Cytomegalovirus (CMV).

Study & Design

• Study Type: Interventional
• Study Design: Not specified