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

Study acronym: KHDT-SGT
StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Collaborators revised (6)
    • Study title shortened, about 5 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06760065
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators: Guangzhou First People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Longgang District People's Hospital of Shenzhen, Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen Baoan District People's Hospital, Foshan Fuxing Chancheng Central Hospital
Conditions
(from sponsor)		 Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
Enrollment 316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov