EFFicacy Optimization Research of Telbivudine Therapy

Study Overview
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Brief Summary
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The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

Official Title
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A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: telbivudine
* Drug: telbivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, from 18 (inclusive) to 65 (inclusive) years of age HBsAg and HBeAg positive for over six months Patient is willing and able to comply with the study drug regimen and all other study requirements Patients must give written informed consent before any assessment is performed Exclusion Criteria: Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit Patient has a history of or clinical signs/symptoms of hepatic decompensation Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC Other protocol-defined inclusion/exclusion criteria may apply

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 Group (Group I)<br>Patients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load: Group I-A: This group of patients was those with HBV DNA ≥300 copies/mL at Week 24 and adefovir was to be added at Week 28; Group I-B: This group of patients was those with HBV DNA <300 copies/mL at Week 24. Telbivudine monotherapy was to be continued until there was a viral breakthrough (confirmed by two examinations with at least 1 month interval with compliance factor excluded) and then adefovir was to be added; The total treatment duration was 104 weeks. | Drug: telbivudine<br>* telbivudine, 600mg, oral, daily<br>* Other names: Sebivo®;|
| Active Comparator: SOC (Standard of Care) Group (Group II)<br>patients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added. | Drug: telbivudine<br>* telbivudine, 600mg, oral, daily<br>* Other names: Sebivo®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II |  | Week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52 |  | week 52 | 
| Serum HBV DNA reduction from baseline at week 104 |  | week 104 | 
| Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline |  | week 104 | 
| Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline |  | week 104 | 
| Serum HBV DNA reduction from baseline at week 52 |  | week 52 | 

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