[Translation] A single-center, randomized, open-label, active-controlled phase Ib/IIa clinical trial to evaluate the tolerability, pharmacodynamics, and pharmacokinetics of multiple-dose hepnofovir fumarate (HTS) tablets in patients with chronic hepatitis B
主要目的: 评价多个剂量组多次给药富马酸海普诺福韦在治疗慢性乙型肝炎患者中的安全性及耐受 性,并与富马酸丙酚替诺福韦安全性及耐受性进行对比; 次要目的: 1.评价连续多次口服富马酸海普诺福韦在慢性乙型肝炎患者给药达到稳态后的药代动力学 特征; 2.评估多次给予富马酸海普诺福韦后的药效学改变情况,主要包括与基线期比较血清 HBV DNA 和血清标志物(HBsAg、HBeAg、HBeAb)的改变情况,并与富马酸丙酚替 诺福韦组疗效进行对比。
[Translation] Primary objective: To evaluate the safety and tolerability of multiple doses of hepnofovir fumarate in the treatment of patients with chronic hepatitis B, and to compare the safety and tolerability with that of tenofovir alafenamide fumarate. Secondary objectives: 1. To evaluate the pharmacokinetic characteristics of hepnofovir fumarate in patients with chronic hepatitis B after continuous oral administration of hepnofovir fumarate to steady state; 2. To evaluate the pharmacodynamic changes after multiple doses of hepnofovir fumarate, mainly including the changes in serum HBV DNA and serum markers (HBsAg, HBeAg, HBeAb) compared with the baseline period, and to compare the efficacy with that of the tenofovir alafenamide fumarate group.