Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

Inclusion Criteria: * Adults with age 20-75 years old; Subjects who are over 70 years of age must be in generally good health; * Confirmed diagnosis of chronic hepatitis B (CHB) virus infection: with positive HBsAg ≧ 6 months prior to the study entry; * Quantitative HBsAg level \< 1,500 IU/ml at screening; * Confirmed HBeAg (-) at screening; * Stable disease: ALT \< 3 x upper limit of normal (ULN), total bilirubin \< 1.5 × ULN (except in Gilbert syndrome) and direct bilirubin \< ULN at screening, serum HBV DNA \< 50 IU/mL for ≧ 1 year prior to study entry; * Stable treatment with nucleos(t)ide regimen (adefovir, entecavir, tenofovir or one of the following combinations: entecavir/adefovir or entecavir/tenofovir) for at least 2 years prior to study entry; * Interferon treatment naïve; * Normal fundoscopic examination by ophthalmologist at screening; defined as no significant or major fundoscopic findings including but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes; * Be able to attend all scheduled visits and to comply with all study procedures; * Be able to provide written informed consent. Exclusion Criteria: * HBeAg-positive chronic hepatitis B; * Documented history of drug resistance to any nucleoside/ nucleotide analogue; * History of treatment with lamivudine or telbivudine prior to the study entry; * Clinically significant abnormalities, other than HBV infection, based upon …