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

• Status: Completed
• Trial end date: 2010-09-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Telbivudine

Criteria

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.