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Efficacy and safety of different durations of keverprazan-based quadruple therapy for Helicobacter pylori eradication: An open-label, multicenter, randomized, noninferiority trial

Efficacy and safety of different durations of keverprazan-based quadruple therapy for Helicobacter pylori eradication: An open-label, multicenter, randomized, noninferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119247
Enrollment
Unknown
Registered
2026-02-25
Start date
2026-02-25
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Helicobacter pylori infection

Interventions

Group A:keverprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, doxycycline 100 mg twice daily, colloidal bismuth pectin 300 mg twice daily for 7 days
Group B:keverprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, doxycycline 100 mg twice daily, colloidal bismuth pectin 300 mg twice daily for 14days

Sponsors

NanJing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years; 2. Positive H. pylori status confirmed by 13C- or 14C-urea breath test and no prior history of eradication therapy; 3. Voluntary participation and provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to any study medication (e.g., penicillin, amoxicillin, doxycycline, keverprazan); 2. Confirmed active peptic ulcer disease; 3. Prior history of H. pylori eradication treatment; 4. Use of antibiotics or bismuth agents within 4 weeks before treatment initiation, or use of H2-receptor antagonists or proton pump inhibitors within 2 weeks; 5. Current use of corticosteroids, nonsteroidal anti-inflammatory drugs, or anticoagulants; 6. History of esophageal or gastric surgery; 7. Pregnancy or lactation; 8. Severe comorbidities, including hepatic, cardiovascular, pulmonary, or renal disease; 9. Alcohol abuse; 10. Gastric mucosa-associated lymphoid tissue lymphoma, malignant tumors, glucose-6-phosphate dehydrogenase deficiency, peptic ulcer disease, or bronchial asthma; 11. Concurrent use of specific medications: atazanavir or rilpivirine, tricyclic antidepressants, levodopa, acetaminophen, guaifenesin/dextromethorphan, monoamine oxidase inhibitors, tramadol, or similar agents.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
adherence;incidence of Adverse Events;

Countries

China

Contacts

Public ContactZhang Zhenyu

NanJing First Hospital

zzy6565@sina.com+86 25 5227 1000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026