The Efficacy and Safety of Keverprazan for Helicobacter Pylori Eradication

NCT06777732 | Not Yet Recruiting Early Phase 1

• 1 other identifier: KY20241217-09
• Study Type: interventional
• Target: 672
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Adverse event

  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 Outcomes (1)

• Helicobacter pylori eradication rate

  four to six weeks after completion of the medication

Study Arms (3)

standard dose keverprazan with high dose amoxicillin group

ACTIVE COMPARATOR

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

Drug: Keverprazan; Drug: Amoxicillin

low dose keverprazan with high dose amoxicillin group

EXPERIMENTAL

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

Drug: Keverprazan; Drug: Amoxicillin

Keverprazan-based bismuth quadruple therapy

EXPERIMENTAL

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

Drug: Keverprazan; Drug: Amoxicillin; Drug: Furazolidone; Drug: Colloidal Bismuth Pectin

Interventions

Keverprazan DRUG

Potassium-competitive acid blocker

Keverprazan-based bismuth quadruple therapy; low dose keverprazan with high dose amoxicillin group; standard dose keverprazan with high dose amoxicillin group

Amoxicillin DRUG

Antibiotic for H. pylori eradication

Keverprazan-based bismuth quadruple therapy; low dose keverprazan with high dose amoxicillin group; standard dose keverprazan with high dose amoxicillin group

Furazolidone DRUG

Antibiotic for H. pylori eradication

Keverprazan-based bismuth quadruple therapy

Colloidal Bismuth Pectin DRUG

Gastric mucosal protectant

Keverprazan-based bismuth quadruple therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65
• Patients who tested positive for H. pylori by 13C or 14C breath test and have not received previous eradication therapy
• Voluntarily join the trial and sign the informed consent form.

You may not qualify if:

• Allergic to the study drug (e.g. penicillin allergy)
• Recent bleeding or within 4 weeks of bleeding history in the stomach or duodenum
• Patients who have previously received eradication therapy for Helicobacter pylori
• Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study
• Patients who have had surgery on the stomach or intestines, which affects the drug's metabolism
• Pregnant or lactating women
• Patients with other serious physiological or psychological conditions, or those with liver or kidney dysfunction
• Patients with Zollinger-Ellison syndrome, gastric mucosal-associated lymphoid tissue lymphoma (MALT), or malignant tumors
• Patients with glucose-6-phosphate dehydrogenase (G-6PD) deficiency, peptic ulcer disease, or bronchial asthma
• Patients with concomitant medications including azatanavir or lopinavir, tricyclic antidepressants, levodopa, paracetamol, codeine phosphate/dextromethorphan, monoamine oxidase inhibitors, tramadol, etc.
• Other factors that the investigator considers unsuitable for participation in the study, etc.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Interventions

Amoxicillin; Furazolidone

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Furans

Central Study Contacts

Zhenyu Zhang

CONTACT

+86 025-87726248; zzy6565@sina.com

Jiahuan Gao

CONTACT

+86 13962393153; gjh2217064988@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share