Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: E-DA Hospital
• Collaborators: Gilead Sciences; Taipei Institute of Pathology
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• age between 25 to 70 years,

• serum HBsAg positivity for more than 6 months,

• positive or negative serum HBeAg,

• serum HBV DNA more than 2,000 IU/mL,

• highest serum ALT > 1 fold of ULN, but < 2 X ULN on at least two occasions (≧ 3 months apart) in the preceding one year,

Exclusion Criteria:

• co-infection with HIV, HCV, or HDV,

• previous exposure to HBV antiviral therapy for more than 12 weeks,

• presence of cirrhosis on histopathology,

• hepatic decompensation defined as serum bilirubin > 2mg/dl and prolonged prothrombin time > 3 seconds,

• concurrent malignant diseases including hepatocellular carcinoma,

• severe co-morbidity with life expectancy < 1year,

• pregnant or lactating women,

• organ transplantation except cornea or hair transplant,

• suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g. alcoholic hepatitis, Wilson disease, Hemochromatosis…etc),

• serum creatinine >1.5mg/dL