Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Inclusion Criteria:

• Male or female, at least 18 years of age.
• Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily.
• Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL).
• Patient is willing to comply with all study requirements.
• Patient is willing and able to provide written informed consent.

Exclusion Criteria:

• Pregnant or nursing (lactating) women. All women must have a negative pregnancy test at the screening visit.
• Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
• Patient is co-infected with hepatitis C virus or HIV.
• Patient has previously taken lamivudine.
• Patient is currently abusing illicit drugs or alcohol.
• Patient is using any investigational drugs or with in the last 30 days.
• Patient is enrolled or plans to enroll in a clinical study involving investigational drug.
• Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir.

Other protocol-defined inclusion/exclusion criteria may apply.