Phase III study of adefovir dipivoxil tablets in patients withcompensated chronic hepatitis B (comparative study against lamivudine).

GlaxoSmithKline K.K.0 个研究点目标入组 100 人开始时间: 2016年12月21日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•Male or female patients aged =16 and <65, with serum HBV DNA = 1 x 106 copies/mL at screening; serum alanine aminotransferase (ALT) level 50-500U/L at screening; with no mutation resistant to ADV and LAM at screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 102
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Liver cancer (including both primary and metastatic); co-infection with HCV or HIV; autoimmune hepatitis (ex. antinuclear titer > 1:160) rather than chronic hepatitis B; a history of transplantation or having a plan for any transplantation; serious complication (e.g., cancer, serious cardiopulmonary disease, uncontrolled diabetes, alcoholism) other than hepatitis B; treatment with overdose NSAIDs, excluding temporary or topical use, within the past 7 days; receiving injection containing glycyrrhizin as the main component (e.g. monoammonium glycyrrhizinate/glycine/Lcystein hydrochloride) within the past 4 weeks; treatment with following drugs (except
•ointment and/or cream etc.) within the past 8 weeks: drugs causing renal impairment, competitors of renal excretion (except temporary use), immunosuppressants, glucocorticoid preparations, drugs causing hepatic impairment; IFNs or HB vaccine within the past 24 weeks; a history of hypersensitivity to nucleoside analogues; pregnant, possibly pregnant or lactating females, or females who wish to be pregnant during the study period.

发起方

GlaxoSmithKline K.K.