Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection

Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection：a Multicenter, Prospective, Randomized Controlled Study

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 .

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Eradication Rate
• Intervention / Treatment: Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin; Drug: Keverprazan Hydrochloride tablets + low dose amoxicillin; Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin（H-KA-10d）

• Study Type: Interventional
• Enrollment (Estimated): 477
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Honglei Chen, MD; Phone Number: 18138728623; Email: chenhlei3@mail.sysu.edu.cn
• Study Contact Backup: Name: Shanshan Wei, MD; Phone Number: 18823305248; Email: weishsh7@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Xiang Peng, MD; Phone Number: 8618320766916; Email: pengx5@mail.sysu.edu
    • Puning, Guangdong, China, 515300
      • Recruiting
      • Puning Overseas Chinese Hospital
      • Contact: Zhihao Huang, MD; Phone Number: 8613580286843; Email: 108382408@qq.com
    • Shenzhen, Guangdong, China, 518033
      • Recruiting
      • Eighth Affiliated Hospital,Sun Yet-san University
      • Contact: Honglei Chen, MD; Phone Number: 18138728623; Email: chenhlei3@mail.sysu.edu.cn
  • Hubei
    • Xiangyang, Hubei, China, 441000
      • Recruiting
      • Xiangyang Hospital of Traditional Chinese Medicine
      • Contact: Jing Zhao, MD; Phone Number: 8615971138823; Email: 42522054@QQ.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Aged 18 to 75 years;
2. 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;
3. Subjects who can understand and comply with the protocol requirements and agree to attend all study visits;
4. 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;
5. Participants agreed to use appropriate medical methods of contraception (except medically sterilized status) during the study.

Exclusion Criteria:

• 1. Participated in other clinical studies within 4 weeks before screening; 2. Pregnant or lactating women; 3. 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; 4. 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; 5. The subjects had Zolie-Ellison syndrome, gastric acid hypersecretion, or a history of gastric acid hypersecretion; 6. 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; 7. "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; 8. 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; 10. 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; 11. Subjects who plan to be hospitalized for surgical treatment during the study; 12. 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; 13. 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; 14. The subjects had clinically significant abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions (PVC), second degree or above atrioventricula

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: H-KA-dual-14; 14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)	Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin; Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 14 day; Other Names: H-KA-14d
Experimental: L-KA-dual-14; 14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral)	Drug: Keverprazan Hydrochloride tablets + low dose amoxicillin; Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 2 times/day, oral, for 14 day; Other Names: L-KA-14d
Experimental: H-KA-dual-10; 10 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)	Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin（H-KA-10d）; Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 10 day; Other Names: H-KA-10d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. pylori eradication rate	Rate of h. pylori successfully eradicated；13C-urea breath testthat will be used to assess this outcome measure	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure.	6 weeks
Medical financial burden	Medical financial burden；Questionnaire that will be used to assess this outcome measure.	6 weeks

Collaborators and Investigators

• Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: Shanshan Wei, MD, The Eighth Affiliated Hospital,sun Yet-san University; Study Chair: Huizhen Xiong, The Eighth Affiliated Hospital,sun Yet-san University; Study Chair: Meifang Ye, The Eighth Affiliated Hospital,sun Yet-san University; Study Chair: Jianfeng Zhong, The Eighth Affiliated Hospital,sun Yet-san University; Study Chair: Wei Liu, The Eighth Affiliated Hospital,sun Yet-san University; Study Chair: Fang Liu, The Eighth Affiliated Hospital,sun Yet-san University; Study Chair: Ting Zhou, The Eighth Affiliated Hospital,sun Yet-san University; Study Chair: Qiucheng Li, The Eighth Affiliated Hospital,sun Yet-san University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Actual): November 10, 2025
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Penicillin G; beta-Lactams; Lactams; Ampicillin; Penicillins; Amoxicillin
• Other Study ID Numbers: 2024-229-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets used and analysed during the current study available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No