Brief Summary

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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

576

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach

1 country

24 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.3 years study duration

Study Start

First participant enrolled

August 1, 2011

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed

5 months until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

4 years

First QC Date

September 20, 2011

Last Update Submit

June 17, 2014

Conditions

Hepatitis B, Chronic

Keywords

Chronic Hepatitis BCompensated Chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

Percentage of patients achieving HBV DNA <300copies/mL at week 156
Week 156
The log10 reduction in HBV DNA from baseline of EFFORT study at week 156
Week 156
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156
Week 156
Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156
Week 156
The percentage of patients with ALT normalization at week 156
Week 156
+4 more secondary outcomes

Study Arms (2)

ROADMAP

EXPERIMENTAL

Drug: telbivudine (ROADMAP)

SOC (Standard of Care)

ACTIVE COMPARATOR

Drug: Telbivudine (Standard of Care)

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.

ROADMAP

Telbivudine (Standard of Care)DRUG

SOC (Standard of Care)

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Treated with telbivudine or combined with adefovir in EFFORT study
Patients are willing to participate in the extension study
Patients provide information consent form

You may not qualify if:

Adjustment of poor compliance by investigators

Contact the study team to confirm eligibility.