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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 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096016
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori

Interventions

Group A:Keverprazan Hydrochloride Tablets 10mg,bid+Amoxicillin 1000mg,tid
Group B:Keverprazan Hydrochloride Tablets 20mg,bid+Amoxicillin 1000mg,tid
Group C:Keverprazan Hydrochloride Tablets 20mg,bid+Amoxicillin 1000mg,bid+Furazolidone 100mg bid+Colloidal Bismuth Pectin 300mg bid

Sponsors

NanJing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.(1) Ages 18-65; 2.(2) Patients who tested positive for H. pylori by 13C or 14C breath test and have not received previous eradication therapy; 3.(3) Voluntarily join the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.(1) Allergic to the study drug (e.g. penicillin allergy); 2.(2) Recent bleeding or within 4 weeks of bleeding history in the stomach or duodenum; 3.(3) Patients who have previously received eradication therapy for Helicobacter pylori; 4.(4) Use antibiotics or bismuth medication 4 weeks before starting the study;use P-CAB or PPI 2 weeks before starting the study; 5.(5) Patients who have had surgery on the stomach or intestines, which affects the drug's metabolism; 6.(6) Pregnant or lactating women; 7.(7) Patients with other serious physiological or psychological conditions, or those with liver or kidney dysfunction; 8.(8) Patients with Zollinger-Ellison syndrome, gastric mucosal-associated lymphoid tissue lymphoma (MALT), or malignant tumors; 9.(9) Patients with glucose-6-phosphate dehydrogenase (G-6PD) deficiency, peptic ulcer disease, or bronchial asthma; 10.(10) Patients with concomitant medications including azatanavir or lopinavir, tricyclic antidepressants, levodopa, paracetamol, codeine phosphate/dextromethorphan, monoamine oxidase inhibitors, tramadol, etc. 11.(11) Other factors that the investigator considers unsuitable for participation in the study, etc.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse reactions;

Secondary

MeasureTime frame
Efficiency;

Countries

China

Contacts

Public ContactZhangZhenyu

NanJing First Hospital

zzy6565@sina.com+86 25 5227 1000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026