Status:
COMPLETED
Tenofovir in Chronic Hepatitis B With Mild ALT Elevation
Lead Sponsor:
E-DA Hospital
Collaborating Sponsors:
Gilead Sciences
Taipei Institute of Pathology
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
25-70 years
Phase:
PHASE4
Brief 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.
Detailed Description
Chronic hepatitis B (CHB) is a serious disease in Taiwan, leading to substantial morbidity and mortality including hepatic failure, liver cirrhosis, and hepatocellular carcinoma (HCC). Recently a larg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01522625
Start Date
January 1 2012
End Date
December 1 2018
Last Update
February 12 2019
Active Locations (6)
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1
Chia-Yi Christine Hospital
Chiayi City, Taiwan, 539
2
E-Da Hospital
Kaohsiung City, Taiwan, 824
3
Taichung Veterans General Hospital
Taichung, Taiwan, 407
4
Chi Mei Medical Center, Liouying
Tainan, Taiwan