The Efficacy and Safety of Keverprazan in Treating H. Pylori：A Randomized Controlled, Multicenter,Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Post-treatment eradication rate of primary treatment participants
研究概览
简要总结
The objective of this clinical trial is to determine whether the interventional behavioral drug Keverprazan in combined with amoxicillin, is effective in treating initial Helicobacter pylori infections in adults and to assess the safety of Keverprazan in the treatment of Helicobacter pylori.
The primary questions it aims to address are:
- What is the eradication rate of Keverprazan in individuals with the first-time H. pylori infection?
- What adverse effects do participants experience while taking the drug Keverprazan?
- To clarify the microecological changes of Keverprazan on the intestinal tract. The researchers will compare the experimental group receiving Keverprazan in combination with amoxicillin dual therapy to the control group receiving Esomeprazole in combination with amoxicillin dual therapy to assess the efficacy and safety of Keverprazan in treating the primary population infected with Helicobacter pylori.
Participants will:
- Take Keverprazan, esomeprazole, and amoxicillin daily for 14 days;
- Researchers will record participants' medication adherence on days 7 and 14, as well as any adverse drug reactions;
- Participants will undergo a urea breath test one month after discontinuing the medication, and the researchers will record the eradication rate.
- 20 Participants in the experimental group and the control group were randomly selected to collect stool for examination 1 month before and 1 month after treatment.
详细描述
Objective: To analyze the clinical effect of keplasen therapy in treating patients with Helicobacter pylori (Hp) infection.
Methods: Participants who were diagnosed with initial Hp infection by 13C/14C-urea breath test (13C/14C-UBT) test at the The First Hospital of Lanzhou University, People's Hospital of Dingxi City and People's Hospital of Tanchang County from March 2025 onwards were selected as the study subjects.
1. Content of the study
- Formulate inclusion and exclusion criteria for Helicobacter pylori infection for the first time, conduct screening, and sign Informed consent.
- The first-time H. pylori infected participants were randomized to the above Keverprazan's group and Esomeprazole's group, and were treated for 14 consecutive days. The urea breath test was repeated 1 month after the end of treatment; during the trial period, the Participants were followed up for drug taking, occurrence of adverse reactions, and review results, to understand the efficacy, safety, and adherence of the combination regimen of Keverprazan and amoxicillin in the treatment of H. pylori infection in the first-treatment population.
- Before and 1 month after the treatment, 20 participants were randomly selected from each group and their feces were collected and sent for examination to summarize the intestinal microecological changes before and after the treatment.
2. Sample size estimation The aim of this study was to validate the non-inferiority of the Keverprazan combination regimen in eradicating H. pylori in first-treatment Participants. Since the review of the previous literature did not reveal any four-or two-combination regimens based on Keverprazan for the treatment of Hp infections, and since Keverprazan belongs to the same novel P-CAB as Vonoprazan, the eradication rate in the Keverprazan's group was estimated to be the same as that in the previous study of Vonoprazan at 90.2%, and that in the Esomeprazole's group at 88.5%, with the non-inferiority margin at 10%, α=0.025, and α=0.025. , α=0.025 (unilateral), and 1-β=0.80, the appropriate sample size was calculated to be 110 cases in each group; assuming a 20% loss-to-follow-up rate, the sample size was 132 cases in each group.
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
- •18~65 years old, gender is not limited;
- •2) H. pylori infection was diagnosed by urea breath test;
- •3) Did not receive H. pylori eradication therapy;
- •4) Informed and consented to participate in this study.
排除标准
- •1) Have serious systemic diseases, major organs such as heart, lung, brain diseases, liver and kidney insufficiency, malignant tumors or other diseases;
- •2) Active peptic ulcer with bleeding, perforation, obstruction, cancer and other complications; And subjects with a past or current history of Zolling-Ellison syndrome's disorders;
- •3) Allergic history of penicillin and regimen related drugs;
- •4) Excessive acid-suppressing drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, etc. were used within 2 weeks before enrollment, or antibiotics were used 4 weeks before enrollment;
- •5) Pregnant or lactating women;
- •6) Other participants were deemed unsuitable by the researchers.
研究组 & 干预措施
Keverprazan combined with amoxicillin
Drug：Keverprazan、Dosage form: tablet, dose: 20mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days；
干预措施: Keverprazan (Drug)
Keverprazan combined with amoxicillin
Drug：Keverprazan、Dosage form: tablet, dose: 20mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days；
干预措施: Amoxicillin (Drug)
Esomeprazole combined with amoxicillin
Drug：Esomeprazole、Dosage form: capsule, dose: 40mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days；
干预措施: Esomeprazole (Drug)
Esomeprazole combined with amoxicillin
Drug：Esomeprazole、Dosage form: capsule, dose: 40mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days；
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Post-treatment eradication rate of primary treatment participants
时间窗: up to 2 months
If the 13C/14C-UBT test of the initial treatment participants was negative at 1 month after 14 days of treatment, the eradication was successful
次要结局
未报告次要终点