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

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

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

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.