Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea
- Conditions
- Chronic Hepatitis B
- Registration Number
- NCT01776814
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 18 < Age < 70
- HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)
- HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)
Exclusion Criteria
- With HCV or other liver disease
- With kidney disease
- decompensated liver cirrhosis
- with hepatocellular carcinoma
- refuse this clinical trials
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method virologic response changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir
- Secondary Outcome Measures
Name Time Method reduction of alanine transaminase changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir Patients will check the level of alanine transaminasel at 3, 6, 9, 12 months after taking entecavir and tenofovir
Trial Locations
- Locations (1)
Gachon University Gil Medical Center, Department of Gastroenterology
🇰🇷Incheon, Korea, Republic of