Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

Gachon University Gil Medical Center100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Chronic Hepatitis B

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Gachon University Gil Medical Center, Department of Gastroenterology

Incheon, South Korea

Outcomes

Primary Outcomes

virologic response

Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir

Time frame: changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir

Secondary Outcomes

reduction of alanine transaminase

Patients will check the level of alanine transaminasel at 3, 6, 9, 12 months after taking entecavir and tenofovir

Time frame: changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir

Central Contacts

Ju Seung Kim, Fellow

CONTACT

+80+32 460 2792 joojoomj@gilhospital.com

Data from ClinicalTrials.gov

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