A comparison of lamivudine plus adefovir and entecavir for chronic hepatitis B patients who had not previously received a nucleoside analogue: A randomized trial
Not Applicable
- Conditions
- Chronic hepatitis B
- Registration Number
- JPRN-UMIN000000884
- Lead Sponsor
- niversity of Tokyo Department of Gastroenterology, Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
The exclusion criteria are as follows: a previous history of a severe drug hypersensitivity against nucleoside analogues, malignancy within 5 years, severe renal disease (BUN more than 40 mg/dl or creatinine more than 2.0 mg/dl) the presence of other forms of liver disease such as auto immune hepatitis, coinfection with hepatitis C, history of liver transplantation, participation in another clinical trial, receiving prohibition medication for combination, and doctors' stop not to register to the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method an incidence of resistant hepatitis B virus to both LAM and ADV, or ETV at 2 and 5 years
- Secondary Outcome Measures
Name Time Method normalization of the alanine aminotransferase level a reduction in the serum HBV DNA level HBeAg loss and seroconversion an incidence of hepatocellular carcinoma five-year survival