3E Extension Study

Nanfang Hospital, Southern Medical University600 enrolled

Overview

The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Chronic Hepatitis B

Interventions

oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeksDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study. * Subjects who are willing to participate the extension study. Exclusion Criteria: * Subjects who could not compliance with the protocol judged by investigators

Locations (28)

Outcomes

Primary Outcomes

Percentages of patients achieving HBV DNA< 300copies/mL at week 144

Time frame: Week 144

Secondary Outcomes

Percentages of patients achieving HBV DNA <300copies/mL at week 48/96

Time frame: Week 48 & 96

The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144

Time frame: Week 48 & 96 &144

Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.

Time frame: Week 48 & 96 & 144

Percentage of patients with ALT normalization at week 48/96/144

Time frame: Week 48 & 96 & 144

Data from ClinicalTrials.gov

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302 Military Hospital Of China