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

NCT06760065 | Not Yet Recruiting Phase 3

• 2 other identifiers: KHDT-SGT1010-Program
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education

Keywords

Helicobacter pylori; Keverprazan Hydrochloride; Susceptibility-guided therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Successful Eradication of Helicobacter pylori

  The proportion of participants who achieve successful eradication of Helicobacter pylori. Eradication is defined as a negative result on the 13C-Urea Breath Test (13C-UBT) conducted at least 4 weeks after the last dose of the study medication. The eradication rate will be calculated as: Eradication Rate=（Number of Participants with Successful Eradication/ Total number of participants）\*100% This outcome will compare the efficacy of Keverprazan Hydrochloride + Amoxicillin dual therapy to susceptibility-guided quadruple therapy in the rescue treatment of H. pylori infection.

  At least 4 weeks after the last dose of study medication

Study Arms (2)

Keverprazan Hydrochloride + Amoxicillin

EXPERIMENTAL

Participants in this arm will receive Keverprazan Hydrochloride 20 mg twice daily and Amoxicillin 0.75 g four times daily for 14 days. This dual therapy aims to evaluate the efficacy of Keverprazan Hydrochloride, a potassium-competitive acid blocker, in combination with Amoxicillin for Helicobacter pylori eradication.

Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin

Susceptibility-Guided Quadruple Therapy

ACTIVE COMPARATOR

Participants will receive susceptibility-guided quadruple therapy based on H. pylori resistance testing: Clarithromycin-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and Clarithromycin 500 mg, twice daily for 14 days. Metronidazole-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and Metronidazole 400 mg, twice daily for 14 days. Levofloxacin-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g (twice daily), and Levofloxacin 500 mg (once daily) for 14 days. Multi-drug resistant strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and either Furazolidone 0.1 g (twice daily) or Tetracycline 500 mg (four times daily) for 14 days. For Amoxicillin-resistant strains, antibiotics will be adjusted based on susceptibility testing.

Drug: Susceptibility-Guided Quadruple Therapy

Interventions

Keverprazan Hydrochloride tablets + high dose amoxicillin DRUG

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.

Keverprazan Hydrochloride + Amoxicillin

Susceptibility-Guided Quadruple Therapy DRUG

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.

Susceptibility-Guided Quadruple Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged ≥18 years and ≤75 years at the time of signing the informed consent.
• Participants who have undergone at least one prior standard H. pylori eradication treatment but failed.
• Current H. pylori infection confirmed by 13C-UBT, or H. pylori culture.
• Participants who, in the investigator's opinion, are able to understand and comply with the study requirements.
• Written informed consent and any required privacy authorization documents signed and dated before the initiation of any study procedures.
• For women of childbearing potential with regular or potential sexual activity with non-sterilized male partners, agreement to use two effective methods of contraception from the time of informed consent until the end of the study.

You may not qualify if:

• Presence of gastric or duodenal ulcer with current or recent bleeding as evidenced by endoscopy.
• Confirmed gastric cancer by endoscopic biopsy.
• Receipt of any investigational drug (including marketed drugs used in post-marketing studies) within 30 days prior to the screening period. Participants who failed screening and did not receive the investigational drug may be included.
• Participants who are investigators, relatives of investigators, or otherwise have conflicts of interest or may be under pressure to participate.
• History of cutaneous or systemic lupus erythematosus.
• Clinical manifestations of upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
• Diagnosis of Zollinger-Ellison syndrome or other gastric acid hypersecretory disorders.
• Known allergy or hypersensitivity to Keverprazan Hydrochloride (including excipients), PPIs, amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, furazolidone, or excipients in 13C-UBT (mannitol, citric acid, or aspartame).
• History of alcohol abuse, illicit drug use, or drug addiction within 12 months prior to screening, or weekly alcohol intake exceeding 21 units (1 unit = 12 oz/300 ml beer, 1.5 oz/25 ml spirits, or 5 oz/100 ml wine).
• Use of antibiotics, bismuth agents, or antiprotozoal drugs within 30 days prior to 13C-UBT, or use of H2 receptor antagonists, PPIs, or interfering drugs (e.g., sodium succinate) within 14 days.
• Concurrent use of drugs contraindicated with clarithromycin (e.g., colchicine, pimozide, ergot derivatives, tadalafil, terfenadine, astemizole, cisapride, simvastatin, lovastatin, atorvastatin, etc.)..Use of pravastatin, fluvastatin, or rosuvastatin is permitted but should be used with caution.
• Concurrent use of strong CYP2C19 or CYP3A4 inhibitors or inducers (e.g., fluconazole, fluoxetine, fluvoxamine, ticlopidine, rifampin, ritonavir, itraconazole, ketoconazole, indinavir, nelfinavir, saquinavir, telithromycin).
• History of surgeries affecting gastric acid secretion, such as gastric resection or vagotomy.
• Significant central nervous, cardiovascular, hepatic, pulmonary, renal, metabolic, gastrointestinal, urological, reproductive, endocrine, or hematological disorders that may affect the study results or participant safety, as judged by the investigator.
• History of any malignancy, including MALT lymphoma.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Guangzhou First People's Hospital: collaborator
• The Seventh Affiliated Hospital of Sun Yat-sen University: collaborator
• Longgang District People's Hospital of Shenzhen: collaborator
• Eighth Affiliated Hospital, Sun Yat-sen University: collaborator
• Bao'an District People's Hospital of Shenzhen: collaborator
• Foshan Fuxing Chancheng Central Hospital: collaborator

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Xiang Peng

CONTACT

+86-020-3825401

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Gastroenterology, The Sixth Affiliated Hospital of Sun Yat-Sen University

Model Details: This study uses a parallel design, where participants are randomly assigned to one of two groups: (1) Keverprazan Hydrochloride combined with Amoxicillin as a dual therapy, or (2) a susceptibility-guided quadruple therapy. Each group will receive the assigned treatment independently, and outcomes will be compared to assess the efficacy and safety of both regimens. Randomization ensures balanced allocation, and the parallel model allows for direct comparison of the two interventions under controlled conditions.

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share