The Efficacy and Safety of Keverprazan for Helicobacter Pylori Eradication

January 15, 2025 updated by: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

The Efficacy and Safety of Different Doses of Keverprazan Dual Therapy and Keverprazan-Based Bismuth Quadruple Therapy for Eradicating Helicobacter Pylori Infection: a Multicenter, Open, Randomized Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

672

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard dose keverprazan with high dose amoxicillin group
Keverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1000mg tid for 14 days
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Keverprazan
Potassium-competitive acid blocker
Experimental: low dose keverprazan with high dose amoxicillin group
Keverprazan Hydrochloride Tablets 10mg bid and Amoxicillin 1000mg tid for 14 days
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Keverprazan
Potassium-competitive acid blocker
Experimental: 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
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Furazolidone
Antibiotic for H. pylori eradication
Drug: Keverprazan
Potassium-competitive acid blocker
Drug: Colloidal Bismuth Pectin
Gastric mucosal protectant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: Within 7 days after completion of therapy
Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
Within 7 days after completion of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori eradication rate
Time Frame: four to six weeks after completion of the medication
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
four to six weeks after completion of the medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20241217-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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