A Multi-center, Randomized, Active Controlled, Double-blind, Parallel Group Comparison Study and Subsequent Open-label Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue

The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to ETV will be verified using the antiviral effect as the index.

本研究旨在评估每日一次、剂量为300mg的GSK548470，用于未接受过任何核酸类似物治疗的日本代偿性慢性乙型肝炎患者的疗效与安全性。在疗效评价环节，本研究将以抗病毒效应为指标，验证GSK548470对比ETV（恩替卡韦，Entecavir）的非劣效性。