The Efficacy and Safety of Keverprazan for Helicobacter Pylori Eradication

NCT ID: NCT06777732

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 672 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-01-31

Brief Summary

The purpose of this study was to compare the efficacy of 14-day eradication of Helicobacter pylori with different doses of Keverprazan combined with Amoxicillin dual therapy and Keverprazan-based bismuth quadruple therapy and compare the adverse reactions, compliance, and factors affecting the efficacy of eradication schemes among different groups.

Detailed Description

Helicobacter pylori infection is a major cause of gastrointestinal diseases, including peptic ulcers, chronic active gastritis, gastric mucosa-associated lymphoid tissue lymphoma, and fatal stomach cancer. At present, the infection rate of Helicobacter pylori in China is as high as 40.66%, and patients are often accompanied by a variety of upper digestive tract diseases, and about 1% of patients will develop malignant tumors. The Kyoto Global Consensus on Helicobacter Pylori Gastritis emphasizes that Hp gastritis is an infectious disease, HP-associated dyspepsia is an organic disease, and eradication of Hp can be used as a primary preventive measure for gastric cancer.At present, the first-line treatment for Hp eradication is a quadruple regimen of bismuth including proton pump inhibitor (PPI), bismuth agent and two antibacterial agents. However, its radical treatment of Hp still has limitations, mainly including increased side effects related to bismuth use and poor medication compliance. Clarithromycin and metronidazole have high drug resistance and high drug cost. Compared to H. pylori which is highly resistant to clarithromycin and metronidazole, resistance to amoxicillin and furazolidone in China and other countries in the Asia-Pacific region remains low.In recent years, the efficacy of high-dose amoxicillin regimen in eradicating H. pylori has been established, and its eradication rate and adverse reactions are similar to that of bismuth quadruple regimen, with better compliance and lower treatment cost. Potassium competitive acid blocker (P-CAB) is a new generation of acid suppressors. Compared with PPI, P-CAB has stronger acid inhibition effect, rapid onset, no acid activation, no influence of CYP2C19 genotype, long half-life, and better night acid inhibition than PPI.Meta-analyses have shown that P-CAB has a higher Helicobacter pylori eradication rate than PPI (90.2% vs. 75.5%). Keverprazan is a new type of potassium competitive acid blocker, whose acid inhibition is not affected by the environmental PH value, and has a more rapid and sustained acid inhibition effect. Keverprazan 20mg has a stable and lasting inhibitory effect on gastric acid. Several clinical studies have shown that Keverprazan is no less effective than lansoprazole in the treatment of reflux esophagitis and duodenal ulcer. The objective of this study was to evaluate the clinical efficacy of different doses of Keverprazan combined therapy and Keverprazan based bismuth quadruple therapy in the eradication of Helicobacter pylori infection. The three programs were compared from the aspects of eradication rate, compliance, adverse reactions and treatment cost, so as to provide reference and basis for the selection of Hp eradication programs, in order to further improve the effectiveness, safety and economy of Hp eradication and reduce the drug resistance of Hp.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard dose keverprazan with high dose amoxicillin group

Keverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1000mg tid for 14 days

Group Type: ACTIVE_COMPARATOR

Keverprazan

Intervention Type: DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type: DRUG

Antibiotic for H. pylori eradication

low dose keverprazan with high dose amoxicillin group

Keverprazan Hydrochloride Tablets 10mg bid and Amoxicillin 1000mg tid for 14 days

Group Type: EXPERIMENTAL

Keverprazan

Intervention Type: DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type: DRUG

Antibiotic for H. pylori eradication

Keverprazan-based bismuth quadruple therapy

Keverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1000mg bid and Furazolidone 100mg bid and Colloidal Bismuth Pectin 300mg bid for 14 days

Group Type: EXPERIMENTAL

Keverprazan

Intervention Type: DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type: DRUG

Antibiotic for H. pylori eradication

Furazolidone

Intervention Type: DRUG

Antibiotic for H. pylori eradication

Colloidal Bismuth Pectin

Intervention Type: DRUG

Gastric mucosal protectant

Interventions

Keverprazan

Potassium-competitive acid blocker

Intervention Type: DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type: DRUG

Furazolidone

Antibiotic for H. pylori eradication

Intervention Type: DRUG

Colloidal Bismuth Pectin

Gastric mucosal protectant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ages 18-65

2. Patients who tested positive for H. pylori by 13C or 14C breath test and have not received previous eradication therapy

3. Voluntarily join the trial and sign the informed consent form.

Exclusion Criteria

1. Allergic to the study drug (e.g. penicillin allergy)

2. Recent bleeding or within 4 weeks of bleeding history in the stomach or duodenum

3. Patients who have previously received eradication therapy for Helicobacter pylori

4. Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study

5. Patients who have had surgery on the stomach or intestines, which affects the drug's metabolism

6. Pregnant or lactating women

7. Patients with other serious physiological or psychological conditions, or those with liver or kidney dysfunction

8. Patients with Zollinger-Ellison syndrome, gastric mucosal-associated lymphoid tissue lymphoma (MALT), or malignant tumors

9. Patients with glucose-6-phosphate dehydrogenase (G-6PD) deficiency, peptic ulcer disease, or bronchial asthma

10. Patients with concomitant medications including azatanavir or lopinavir, tricyclic antidepressants, levodopa, paracetamol, codeine phosphate/dextromethorphan, monoamine oxidase inhibitors, tramadol, etc.

11. Other factors that the investigator considers unsuitable for participation in the study, etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhenyu Zhang

Director of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhenyu Zhang

Role: CONTACT

zzy6565@sina.com

+86 025-87726248

Jiahuan Gao

Role: CONTACT

gjh2217064988@163.com

+86 13962393153

Other Identifiers

KY20241217-09

Identifier Type: -

Identifier Source: org_study_id