Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate 6-8 weeks after the end of eradication treatment
研究概览
简要总结
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.
详细描述
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1. Study duration: Starting from the date of ethics approval and clinical registration completion, the project will last for 1 year. If you agree to participate in this study, you will be assigned to one of the three treatment groups through randomization (with a 33% probability for each group), with 138 subjects in each group.
The study is divided into a screening phase and a treatment phase, with a total of 4 visit points:
Screening period: -7 to 0 days
- Obtain informed consent;
- Collect demographic information and baseline characteristics of the subject;
- Record medical history and current treatment, concomitant medications (including prescription and over-the-counter drugs);
- Vital signs, physical examination;
- H. pylori test;
- Review inclusion and exclusion criteria;
- Eligible subjects will be randomized to receive assigned treatment based on randomization numbers.
Visit period V2 (telephone visit):
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Keverprazan Dual Therapy for 10 Days
Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.
干预措施: Keverprazan 10 days (Drug)
Keverprazan Dual Therapy for 14 Days
Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
干预措施: Keverprazan 14 days (Drug)
Rabeprazole Quadruple Therapy for 14 Days
Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.
干预措施: Rabeprazole (Drug)
结局指标
主要结局
H. pylori eradication rate 6-8 weeks after the end of eradication treatment
时间窗: 8-10weeks
Efficacy Endpoints: The primary efficacy endpoint is the proportion of subjects achieving successful Helicobacter pylori eradication 6-8 weeks after completion of first-line therapy. Eradication rates will be reported with two-sided 95% confidence intervals (CIs) calculated using the Clopper-Pearson method. Inter-group differences will be estimated along with their 95% CIs using the Miettinen-Nurminen method. Inter-group comparisons will be performed using the chi-square test or Fisher's exact test, as appropriate.
次要结局
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(From first dose of study drug until 8 weeks after last dose)
研究者
Ye Jun
Professor of Treatment
Second Affiliated Hospital, School of Medicine, Zhejiang University