Comparison of Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy for Helicobacter Pylori Rescue Treatment
Summary
This study aims to evaluate the efficacy and safety of Keverprazan Hydrochloride combined with Amoxicillin in dual therapy compared to susceptibility-guided quadruple therapy in the treatment of Helicobacter pylori (H. pylori) infections requiring rescue therapy. H. pylori is a common infectious disease associated with peptic ulcers, gastric cancer, and mucosa-associated lymphoid tissue lymphoma. However, the increasing resistance of H. pylori to antibiotics has reduced the eradication rates of standard therapies. Potassium-competitive acid blockers (P-CABs), such as Keverprazan Hydrochloride, provide faster and more sustained gastric acid suppression compared to traditional proton pump inhibitors (PPIs), making them a promising option for H. pylori treatment. This multicenter, randomized controlled trial will provide critical evidence comparing the effectiveness of Keverprazan-based dual therapy to susceptibility-guided quadruple therapy, aiming to establish optimized rescue therapy guidelines for H. pylori eradication.
Timeline
- Start
- 2025-01-15
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 0.75 g | — |
| Subject | Amoxicillin | Other / unclassified | 1 g | — |
| Comparator | Bismuth Potassium Citrate | Unknown | 220 mg | — |
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Comparator | Esomeprazole | Small molecule | 20 mg | — |
| Comparator | Furazolidone | Small molecule | 0.1 g | — |
| Subject | Keverprazan | Unknown | 20 mg | — |
| Comparator | Levofloxacin | Small molecule | 500 mg | — |
| Comparator | Metronidazole | Small molecule | 400 mg | — |
| Comparator | Tetracycline | Unknown | 500 mg | — |