Comparison of Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy for Helicobacter Pylori Rescue Treatment

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
Interventions
DRUG

Keverprazan Hydrochloride tablets + high dose amoxicillin

Keverprazan Hydrochloride, a potassium-competitive acid blocker (P-CAB), is administered at a dose of 20 mg twice daily in combination with Amoxicillin 0.75 g four times daily for 14 days. This dual therapy is designed to provide rapid and sustained gastric acid suppression and evaluate its efficacy in eradicating Helicobacter pylori.

DRUG

Susceptibility-Guided Quadruple Therapy

Participants in this arm will receive quadruple therapy tailored to individual H. pylori resistance profiles, including a proton pump inhibitor (Esomeprazole 20 mg), Bismuth Potassium Citrate 220 mg, and two antibiotics selected based on susceptibility testing (e.g., Amoxicillin, Clarithromycin, Metronidazole, Levofloxacin, or Furazolidone). The regimen is administered for 14 days to optimize eradication outcomes.

All Listed Sponsors
collaborator

Guangzhou First People's Hospital

OTHER

collaborator

The Seventh Affiliated Hospital of Sun Yat-sen University

OTHER

collaborator

Longgang District People's Hospital of Shenzhen

OTHER

collaborator

Eighth Affiliated Hospital, Sun Yat-sen University

OTHER

collaborator

Bao'an District People's Hospital of Shenzhen

UNKNOWN

collaborator

Foshan Fuxing Chancheng Central Hospital

UNKNOWN

lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

NCT06760065 - Comparison of Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy for Helicobacter Pylori Rescue Treatment | Biotech Hunter | Biotech Hunter