Chronic Hepatitis B
Conditions
Keywords
Entecair, Tenofovir
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.
Interventions
None listed
Sponsors
Gachon University Gil Medical Center
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactJu Seung Kim, Fellow
Outcome results
None listed