Clinical trial NCT06777732: The Efficacy and Safety of Keverprazan for Helicobacter Pylori Eradication
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Helicobacter Pylori Infection
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adverse event
timeFrame: Within 7 days after completion of therapy
Secondary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: four to six weeks after completion of the medication
Other outcomes:
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Study officials:
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