Hepatitis B, Chronic
Conditions
Keywords
Chronic Hepatitis B, Compensated Chronic hepatitis B
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
Interventions
DRUGtelbivudine (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.
DRUGTelbivudine (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.
Sponsors
Major Science and Technology Special Project of China Eleventh Five-year
Novartis
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II | Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of patients achieving HBV DNA <300copies/mL at week 156 | Week 156 |
| Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156 | Week 156 |
| sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration | week 52 of off-treatment |
| percentage of hepatitis flare at week 52 of off-treatment duration | week 52 of off-treatment |
| Percentage of patients with HBV DNA breakthrough at week 156 | Week 156 |
Countries
China
Outcome results
None listed