Dose Intensification of Potassium-Competitive Acid Blocker in Optimizing Regimen Duration and Medication for Helicobacter pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500110714

Enrollment

Unknown

Registered

2025-10-20

Start date

2025-10-30

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Helicobacter pylori infection

Interventions

Keverprazan Dual Group (oral administration, 14 days):Keverprazan 20 mg TID Amoxicillin1000 mg TID

Keverprazan Quadruple Short-Course Group (oral administration, 10 consecutive days):Keverprazan 20 mg tid Bismuth Potassium Citrate 600 mg bid Amoxicillin 1000 mg bid Tetracycline 500 mg tid

Keverprazan Quadruple Extended Group (oral administration, 14 consecutive days): Keverprazan 20 mg bid Bismuth Potassium Citrate 600 mg bid Amoxicillin 1000 mg bid Tetracycline 500 mg tid

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-70 years, gender unrestricted; 2.H. pylori-positive confirmed by 13C-urea breath test (13C-UBT) at screening, requiring eradication therapy; 3.No prior H. pylori eradication treatment received.

Exclusion criteria

Exclusion criteria: 1. Allergy to any of the study medications (Keverprazan, amoxicillin, tetracycline, or bismuth-containing compounds); 2. Presence of Zollinger–Ellison syndrome; 3. Known acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury, or acute duodenal mucosal injury at the time of screening; 4. Undergoing or having undergone gastrointestinal surgery (e.g., gastric surgery, vagotomy, or craniectomy) within 1 month prior to randomization that could affect gastric acid secretion; 5. Severe underlying diseases, including hepatic or renal dysfunction, immunosuppression, malignancy, or serious central nervous system, cardiovascular, or respiratory disorders; 6. Use of antibiotics, bismuth-containing compounds, or traditional Chinese medicines with antibacterial effects within 4 weeks prior to ^13C-urea breath test (UBT) screening, or use of proton pump inhibitors (PPIs) or potassium-competitive acid blockers (P-CABs) within 2 weeks prior to ^13C-UBT screening; 7. History of drug abuse or alcohol dependence; 8. Pregnant or breastfeeding women, or participants unwilling to use contraception during the study period; 9. Inability or unwillingness to provide written informed consent.

Design outcomes

Primary

Measure	Time frame
Eradication rate of Helicobacter pylori ;	—

Secondary

Measure	Time frame
Compliance;Incidence rate of adverse reactions;	—

Countries

China

Contacts

Public ContactXiuli zuo

Qilu Hospital of Shandong University

11011912315@163.com+86 11011912315

Outcome results

None listed

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