EFFORT Extension Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-12-31

Brief Summary

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* 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

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Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ROADMAP

Group Type EXPERIMENTAL

telbivudine (ROADMAP)

Intervention Type 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.

SOC (Standard of Care)

Group Type ACTIVE_COMPARATOR

Telbivudine (Standard of Care)

Intervention Type 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.

Interventions

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telbivudine (ROADMAP)

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.

Intervention Type DRUG

Telbivudine (Standard of Care)

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinlin Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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