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

Sponsor

Gachon University Gil Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01776814

Collaborator

(none)

100

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Time Perspective:

Prospective

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2013

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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 (-)