NCT01529255 - EFFORT Extension Study | Crick

Overview

* The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy. * To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA\<300copies/ml with over 12 months consolidation treatment

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

576

Conditions

Hepatitis B, Chronic

Interventions

telbivudine (ROADMAP)DRUG

Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA\<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.

Telbivudine (Standard of Care)DRUG

Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA\<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treated with telbivudine or combined with adefovir in EFFORT study * Patients are willing to participate in the extension study * Patients provide information consent form Exclusion Criteria: * Adjustment of poor compliance by investigators

Locations (24)

302 Military Hospital Of China

Outcomes

Primary Outcomes

The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II

Time frame: Week 48

Secondary Outcomes

Percentage of patients achieving HBV DNA <300copies/mL at week 156

Time frame: Week 156

The log10 reduction in HBV DNA from baseline of EFFORT study at week 156

Time frame: Week 156

Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156

Time frame: Week 156

Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156

Time frame: Week 156

The percentage of patients with ALT normalization at week 156

Time frame: Week 156

Percentage of patients with HBV DNA breakthrough at week 156

Time frame: Week 156

Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156

Time frame: Week 156

sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration

Time frame: week 52 of off-treatment

percentage of hepatitis flare at week 52 of off-treatment duration

Time frame: week 52 of off-treatment