Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

A Randomized, Open-label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-positive, Compensated Chronic Hepatitis B (CHB)

This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.

Inclusion Criteria:

• Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B
• Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

• Pregnant or breastfeeding
• Unwilling to use double barrier method of contraception
• Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
• Received Hepatitis B therapy in the past
• Use of immunomodulatory therapy in past 12 months
• History of or symptoms of hepatic decompensation or pancreatitis
• Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
• Concurrent medication likely to preclude compliance with schedule of evaluations
• Use of other investigational drugs within 30 days of enrollment
• Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply