Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Combination With Entecavir in Comparison With Entecavir Alone in Patients With Chronic HBV Who Are HBeAg Positive
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 37
- 主要终点
- The value of serum HBsAg decreased from baseline
研究概览
简要总结
The experiment is divided into two parts: Part 1 and Part 2.Part 1 was the initial treatment patient and Part 2 was the treated patient.
详细描述
About 125 subjects were planned to be included and assigned to the experimental group and the control group according to 4:1.At the same time, a liver biopsy group was set up in each part of the population to receive liver biopsy during the screening period and 48 weeks after completion of drug administration, which was used to detect HBV DNA, cccDNA, HBsAg, and evaluate the degree of liver inflammation and fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HBV infection population
- •HBeAg positive
- •HBsAg≥250 IU/mL
- •No cirrhosis
排除标准
- •AST>5×ULN
- •Platelet count less than 90E+09/L
- •TBil>1.5×ULN
- •albumin<35 g/L
- •AFP>50 ng/mL
研究组 & 干预措施
Combination group
Subjects will receive 96 weeks of GLS4+RTV+ETV.
干预措施: GLS4 (Drug)
Combination group
Subjects will receive 96 weeks of GLS4+RTV+ETV.
干预措施: RTV (Drug)
Combination group
Subjects will receive 96 weeks of GLS4+RTV+ETV.
干预措施: ETV (Drug)
Entecavir monotherapy
Subjects received 96 weeks of entecavir treatment
干预措施: ETV (Drug)
结局指标
主要结局
The value of serum HBsAg decreased from baseline
时间窗: 48 weeks after dosing
The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.
次要结局
- The value of HBV DNA decreased from baseline(24 weeks after dosing)
- The value of serum HBeAg decreased from baseline(24 weeks after dosing)
- The value of serum HBsAg decreased from baseline(24 weeks after dosing)