Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.

Inclusion Criteria:

• Male or female 16 to 65 year of age
• Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
• Willing and able to comply with the study drug regimen
• Written informed consent before any assessment

Exclusion Criteria:

• Patient has a history of/or clinical signs/symptoms of hepatic decompensation
• Patient has a history of HCC or findings suggestive of possible HCC
• Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
• History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
• Patient has received IFN or other immunomodulatory treatment with 12 months before screening
• Previous treatment history with NRTIs

Other protocol-defined inclusion/exclusion criteria may apply.