Overview

This trial is active, not recruiting.

Condition hepatitis b, chronic
Treatments telbivudine (roadmap), telbivudine (standard of care)
Phase phase 4
Sponsor Nanfang Hospital of Southern Medical University
Collaborator Major Science and Technology Special Project of China Eleventh Five-year
Start date August 2011
End date August 2015
Trial size 576 participants
Trial identifier NCT01529255, MOH-05

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
Principal investigator Jinlin Hou, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Nanfang Hospital of Southern Medical University.