Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

Study Overview
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Brief Summary
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The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in selected patients

Official Title
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A Single-arm, Multicenter, Open-label, 52-week Treatment, Extension Study to CLDT600ACN04 Study to Evaluate the Efficacy (Including Histological Improvement) and Safety in Fourth to Sixth Year of Telbivudine Treatment in Patients With Chronic Hepatitis B

Conditions
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Compensated Chronic Hepatitis B

Intervention / Treatment
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* Drug: telbivudine/LDT600


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug. Patient was not discontinued from the previous CLDT600ACN04 study. Adult patients with CHB (HBeAg positive or HBeAg negative). HBV DNA PCR undetectable in recent 12 months. Exclusion Criteria: Pregnant or breastfeeding, or has plan of pregnant during study period. Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit. Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: telbivudine/LDT600<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations. |  | Visit 2 (week 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment |  | weeks 1, 24, 52 and 24 weeks post-treatment | 
| To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies |  | weeks 24 and 52, 24 weeks post-treatment | 
| To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion |  | weeks 24, 52 and 24 weeks post-treatment | 
| To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015 |  | Visit 2 (week 1) | 

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