Skip to content

Keverprazan combined with different doses of amoxicillin dual therapy for first-line Helicobacter pylori eradication: a prospective, randomized controlled trial

Keverprazan combined with different doses of amoxicillin dual therapy for first-line Helicobacter pylori eradication: a prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122928
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Helicobacter pylori infection

Interventions

the bismuth-containing quadruple therapy (BQT) group:Esomeprazole 20 mg bid + bismuth potassium citrate 240 mg bid + amoxicillin 1.0 g bid + clarithromycin 500 mg bid for 14 days
KA Dual Therapy Group:Keverprazan 20 mg bid + amoxicillin 1.0 g bid for 14 days
KHA Dual Therapy Group:Keverprazan 20 mg bid + amoxicillin 1.0 g tid for 14 days

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years. 2. Confirmed H. pylori infection meeting any of the following criteria within the past 3 months: (1) positive ¹³C- or ¹4C-urea breath test with a value = twice the upper limit of normal; (2) positive histopathological examination or bacterial culture for H. pylori. 3. No previous history of H. pylori eradication therapy; patients who have taken anti-H. pylori medication for 5 consecutive days or more are considered to have received prior eradication therapy and will be excluded. 4. Willingness to participate in the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to any of the drugs used in this study. 2. Patients who had history of gastric surgery. 3. Patients with insufficiency in vital organs, such as the lungs, heart, liver and kidneys. 4. Patients who had taken acid-suppressing drugs (such as potassium-competitive acid blockers, proton-pump inhibitors, or H2 receptor antagonists) within two weeks, or antibiotics, bismuth agents, or traditional Chinese medicine with antibacterial activity within four weeks before enrollment. 5. Pregnant women; lactating women who are unwilling to suspend breastfeeding during the study treatment period and within 2 days after the last dose; female subjects of childbearing potential who are unwilling to adopt medically approved effective contraceptive measures during the study period and within 4 weeks after the last dose. 6. Patients with psychiatric symptoms, drug addiction, severe neurocognitive disorders and other poor compliance or unable to cooperate.

Design outcomes

Primary

MeasureTime frame
Eradication rate of Helicobacter pylori;Adverse events;

Secondary

MeasureTime frame
Compliance;

Countries

China

Contacts

Public ContactZhang Jinyan

The First Affiliated Hospital of Xiamen University

zjywyq2002@163.com+86 151 6004 2319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026