Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection：a Multicenter, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 477
- 试验地点
- 4
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
Eradication of HP can significantly improve and reduce HP-related diseases. A 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 85%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. High-dose proton pump inhibitors (PPI) combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. However, the acid inhibition effect of PPI mainly depends on the degree of individual metabolism of proton pump,which might influence the eradication effect. Keverprazan, a new competitive potassium acid blocker(P-CAB), is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with PPIs. This study aimed to evaluate two different doses of therapy (1 g b.i.d. vs. 1.0 g t.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of Keverprazan-amoxicillin dual therapy .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 75 years;
- •Adult subjects who voluntarily signed written informed consent approved by the ethics committee to consent to participate in this study before the start of any study procedure;
- •Subjects who can understand and comply with the protocol requirements and agree to attend all study visits;
- •During the screening phase, patients who were Hp positive and required Hp eradication therapy as judged by the investigator, and patients who had failed Hp eradication for the first time;
- •Participants agreed to use appropriate medical methods of contraception (except medically sterilized status) during the study.
排除标准
- •1. Participated in other clinical studies within 4 weeks before screening;
- •Pregnant or lactating women;
- •Known allergy to keverprazan, esomeprazole, penicillins or other beta-lactams, macrolide antibiotics, nitrofuran antibiotics, or bismuth (including any relevant adjuvants). If skin sensitivity testing (skin testing) was required, it was performed at visit 1 according to routine medical practice;
- •Participants had a history of drug (including but not limited to opioids) abuse or alcohol abuse (> 14 units of alcohol per week, 1 unit of alcohol ≈360mL of approximately 5% beer or 45 ml of approximately 40% spirits or 150 ml of approximately 12% wine) in the year before the screening visit;
- •The subjects had Zolie-Ellison syndrome, gastric acid hypersecretion, or a history of gastric acid hypersecretion;
- •The subject has undergone previous surgery or operation that may affect gastric acid secretion or drug absorption, such as subtotal gastrectomy, total gastrectomy, vagotomy, intestinal resection, etc. Simple surgery for perforation, appendectomy, cholecystectomy, and endoscopic resection of benign tumors are acceptable;
- •"Warning" symptoms such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia that might indicate the presence of a malignant GI lesion, unless a malignant lesion was ruled out by endoscopy;
- •A history of malignancy within 5 years before screening (participants were allowed to participate if they had been cured of skin basal cell carcinoma or cervical carcinoma in situ); 9.. Upper gastrointestinal endoscopy showed acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric or duodenal mucosal injury;
- •According to the investigator's judgment, the subject has uncontrolled and unstable liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, hematological, central nervous system or mental diseases, etc., and participating in the study may affect the safety of the subject or the interpretation of the study results;
- •Subjects who plan to be hospitalized for surgical treatment during the study;
- •H2-receptor antagonist or PPI use within 14 days prior to screening 13C-urea breath test; During the screening period, antibiotics, bismuth and some traditional Chinese medicine with antibacterial effect were taken within 28 days before 13C-urea breath test;
- •Abnormal laboratory test results at screening in any of the following: AST > upper limit of normal (ULN); ALT > Upper limit of normal (ULN); Total bilirubin > ULN; creatinine > 1.5 times ULN;
- •The subjects had clinically significant abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions (PVC), second degree or above atrioventricula
研究组 & 干预措施
H-KA-dual-14
14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral
+Amoxicillin 1000mg/ time, 3 times/day, oral)
干预措施: Keverprazan Hydrochloride tablets + high dose amoxicillin (Drug)
L-KA-dual-14
14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral
+Amoxicillin 1000mg/ time, 2 times/day, oral)
干预措施: Keverprazan Hydrochloride tablets + low dose amoxicillin (Drug)
H-KA-dual-10
10 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral
+Amoxicillin 1000mg/ time, 3 times/day, oral)
干预措施: Keverprazan Hydrochloride tablets + high dose amoxicillin（H-KA-10d） (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 6 weeks
Rate of h. pylori successfully eradicated；13C-urea breath testthat will be used to assess this outcome measure
次要结局
- Adverse Event(6 weeks)
- Medical financial burden(6 weeks)
研究者
chenhonglei
Doctor
Eighth Affiliated Hospital, Sun Yat-sen University