Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

NCT06412640 | Not Yet Recruiting Phase 4

• 1 other identifier: KY20240419-15
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of keverprazan with different doses of amoxicillin for Helicobacter Pylori.

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Subjects were seen again 4 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT.

  at least four weeks after completion of the medication

Secondary Outcomes (2)

• Adverse even

  Within 7 days after completion of therapy

• Compliance Rate

  Within 7 days after completion of therapy

Study Arms (2)

high dose amoxicillin with keverprazan group

ACTIVE COMPARATOR

Patients need to take keverprazan 20mg bid and amoxicillin 1000mg tid for 14 days.

Drug: Keverprazan; Drug: Amoxicillin

low dose amoxicillin with keverprazan group

EXPERIMENTAL

Patients need to take keverprazan 20mg bid and amoxicillin 1000mg bid for 14 days.

Drug: Keverprazan; Drug: Amoxicillin

Interventions

Keverprazan DRUG

Potassium-competitive acid blocker

Also known as: Potassium-competitive acid blocker

high dose amoxicillin with keverprazan group; low dose amoxicillin with keverprazan group

Amoxicillin DRUG

Antibiotic for H. pylori eradication

Also known as: Antibiotic for H. pylori eradication

high dose amoxicillin with keverprazan group; low dose amoxicillin with keverprazan group

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with Helicobacter pylori positivity through 13C-UBT or 14C-UBT
• Patients who have not received eradication treatment for Helicobacter pylori in the past, or who have failed eradication in the early stage but have not received eradication treatment within six months
• Voluntarily participate in this experiment and sign an informed consent form

You may not qualify if:

• Allergies to research drugs (such as those allergic to penicillin, amoxicillin, keverprazan)
• Patients with peptic ulcer
• Patients who have received Helicobacter pylori eradication treatment within six months
• Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study
• Using corticosteroids, non steroidal anti-inflammatory drugs, or anticoagulants
• Those who are using atazanavir, nelfinavir, rilpivirine, itraconazole, tyrosine kinase inhibitors (imatinib, gefitinib, etc.), digoxin, and methyl digoxin
• History of esophageal or gastric surgery
• Pregnant or lactating women
• Suffering from serious concomitant diseases such as liver disease, cardiovascular disease, lung disease, or kidney disease
• Excessive drinking
• Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant neoplastic diseases

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Related Publications (5)

• Li Y, Choi H, Leung K, Jiang F, Graham DY, Leung WK. Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):553-564. doi: 10.1016/S2468-1253(23)00070-5. Epub 2023 Apr 20.

  PMID: 37086739 BACKGROUND

• Zhou XZ, Lyu NH, Zhu HY, Cai QC, Kong XY, Xie P, Zhou LY, Ding SZ, Li ZS, Du YQ; National Clinical Research Center for Digestive Diseases (Shanghai), Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA), Helicobacter pylori Study Group of Chinese Society of Gastroenterology and Chinese Alliance for Helicobacter pylori Study.. Large-scale, national, family-based epidemiological study on Helicobacter pylori infection in China: the time to change practice for related disease prevention. Gut. 2023 May;72(5):855-869. doi: 10.1136/gutjnl-2022-328965. Epub 2023 Jan 23.

  PMID: 36690433 BACKGROUND

• Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print.

  PMID: 35944925 BACKGROUND

• Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Xie Y, Shu X, Lu NH, Zhu Y. Optimization of vonoprazan-amoxicillin dual therapy for eradicating Helicobacter pyloriinfection in China: A prospective, randomized clinical pilot study. Helicobacter. 2022 Aug;27(4):e12896. doi: 10.1111/hel.12896. Epub 2022 Apr 25.

  PMID: 35466521 BACKGROUND

• Zhou S, Xie L, Zhou C, Wang L, Chen J, Ding S, Zhu B, Su M, Shao F. Keverprazan, a novel potassium-competitive acid blocker: Multiple oral doses safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects. Clin Transl Sci. 2023 Oct;16(10):1911-1922. doi: 10.1111/cts.13598. Epub 2023 Aug 2.

  PMID: 37533172 BACKGROUND

MeSH Terms

Interventions

Amoxicillin; Anti-Bacterial Agents

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; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zhenyu Zhang

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Zhang

CONTACT

+86 025-87726248; zzy6565@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share