The Efficacy and Safety of IHCs Treated With Pegylated Interferon α2b Based on Pulse Theray or Sequential Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Extent of HBsAg decrease at 48 weeks
研究概览
简要总结
A multicenter, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml) to enter this study, and to compare the feasibility, effectiveness and safety treated with Pegylated Interferon α2b Continuous therapy or Pulse therapy in immune-controlled chronic hepatitis B patients.
详细描述
Patients:chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml). The study patients were divided into two groups.Group A (PEG IFN α- 2b continuous group): PEG IFN was injected subcutaneously once a week from the first day of baseline α- 2b 180 μg. The total course of treatment should not exceed 96 weeks.Group B (PEG IFN α- 2b pulse group): from the first day of baseline, PEG IFN was injected subcutaneously α- 2b 180 μg. Every 8 weeks of injection, stop for 4 weeks, and conduct it periodically.Two groups at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72weeks, 84 weeks, 96 weeks and the 12th and 24th weeks after drug withdrawal, and corresponding examinations were carried out at each follow-up.Check and record adverse events and concomitant medication in detail, and evaluate the compliance of subjects; Blood samples were retained and transported to the laboratory for HBV at baseline, 24 weeks, 48weeks, 72, 96, and 12 and 24 after drug withdrawal.DNA quantification and detection of hepatitis B virus markers.The efficacy and safety were evaluated after the study.
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
- •age 18 to 65 years, both male and female (including 18 and 65 years old);
- •HBV DNA≤2000 IU/ml and HBeAg negative;
- •HBsAg positive for more than 6 months, and HBsAg≤1000 IU/ml;
- •ALT≤ULN at screening (discontinue liver-protecting enzyme-lowering drugs for at least 2 weeks);
- •A negative urine or serum pregnancy test (for women of childbearing age) within 24 hours before the first dose;
- •B-ultrasound or fibroscan suggest no liver cirrhosis;
- •Willing to accept treatment and sign informed consent.
排除标准
- •Participants with other hepatotropic viruses or human immunodeficiency virus co-infection;
- •other chronic non-viral liver diseases or decompensated liver diseases;
- •drug abuse;
- •severe psychiatric disease;
- •uncontrolled thyroid disease or diabetes;
- •pregnancy or lactation.
结局指标
主要结局
Extent of HBsAg decrease at 48 weeks
时间窗: 48 weeks
Decreasing level and difference of HBsAg in different treatment groups after 48 week treatment
次要结局
- The decreasing extent of HBsAg level at 96 weeks(96 weeks)
- HBsAg clearance at the end of 96 weeks of treatment(96 weeks)