EFFORT Extension Study

Study Overview
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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

Official Title
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A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: telbivudine (ROADMAP)
* Drug: Telbivudine (Standard of Care)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROADMAP<br> | Drug: telbivudine (ROADMAP)<br>* 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.<br>|
| Active Comparator: SOC (Standard of Care)<br> | Drug: Telbivudine (Standard of Care)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percentage of patients with HBV DNA breakthrough 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis B, Compensated Chronic hepatitis B