[Translation] A phase II/III, multicenter, randomized, double-blind study to evaluate the efficacy and safety of different sequential therapies of clevudine capsules in the treatment of patients with chronic hepatitis B virus infection who have been treated with nucleoside (acid) analogs compared with entecavir alone
主要目的:评估克来夫定(CLV)胶囊不同序贯疗法对比恩替卡韦(ETV)单药在核苷(酸)类似物(NAs)经治的慢性乙型肝炎病毒(HBV)感染患者中的血清学应答疗效[乙型肝炎病毒表面抗原(HBsAg)转阴率和HBsAg下降> 1 lg的受试者比例]。 次要目的:
①评估CLV胶囊不同序贯疗法对比ETV单药在NAs经治的慢性HBV感染患者中的其他血清学应答疗效; ②评估CLV胶囊不同序贯疗法对比ETV单药在NAs经治的慢性HBV感染患者中的病毒学应答疗效; ③评估CLV胶囊不同序贯疗法对比ETV单药在NAs经治的慢性HBV感染患者中的组织学应答疗效; ④评估CLV胶囊不同序贯疗法对比ETV单药在NAs经治的慢性HBV感染患者中的生化学应答疗效; ⑤评估CLV胶囊不同序贯疗法对比ETV单药在NAs经治的慢性HBV感染患者中耐药性; ⑥评估CLV胶囊不同序贯疗法对比ETV单药在NAs经治的慢性HBV感染患者中的安全性。
[Translation] Primary objective: To evaluate the efficacy of different sequential therapies of clevudine (CLV) capsules versus entecavir (ETV) alone in the serological response [hepatitis B virus surface antigen (HBsAg) negative conversion rate and proportion of subjects with HBsAg decrease > 1 lg] in patients with chronic hepatitis B virus (HBV) infection who have been treated with nucleos(t)ide analogs (NAs). Secondary objectives:
① To evaluate the efficacy of different sequential therapies of CLV capsules compared with ETV monotherapy in other serological responses in patients with chronic HBV infection treated with NAs; ② To evaluate the efficacy of different sequential therapies of CLV capsules compared with ETV monotherapy in patients with chronic HBV infection treated with NAs; ③ To evaluate the efficacy of different sequential therapies of CLV capsules compared with ETV monotherapy in patients with chronic HBV infection treated with NAs; ④ To evaluate the efficacy of different sequential therapies of CLV capsules compared with ETV monotherapy in patients with chronic HBV infection treated with NAs in biochemical responses; ⑤ To evaluate the drug resistance of different sequential therapies of CLV capsules compared with ETV monotherapy in patients with chronic HBV infection treated with NAs; ⑥ To evaluate the safety of different sequential therapies of CLV capsules compared with ETV monotherapy in patients with chronic HBV infection treated with NAs.