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H. Pylori InfectionPhase 4NCT06412640

Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

A Phase 4 study testing Keverprazan and Amoxicillin in people with H. Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
H. Pylori Infection
What is being tested?
Keverprazan and Amoxicillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 1 Feb 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Zhenyu Zhang contact

+86 025-87726248

zzy6565@sina.com

About this study

Official title: Eradication of Helicobacter Pylori by 14-day Dual Therapy of Keverprazan in Combination With Low-dose and High-dose Amoxicillin: a Prospective, Single-center, Developmental-label, Randomized Controlled Study

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

Read the detailed description

This study is a prospective, single-center, open-label, randomized, parallel-controlled trial. A total of 268 H. pylori positive patients needed to be recruited and were randomized into 2 groups in 1:1 ratio, Group A was the control group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. Group B was the experimental group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. All the above regimens were used for eradication of H. pylori. During the 14-day eradication treatment, all subjects were instructed and asked to record their adverse drug reactions and compliance. On days 7 and 14 of treatment, researchers followed up with patients via WeChat or phone to determine adverse reactions and compliance, and observed and recorded whether subjects experienced any adverse reactions such as nausea, diarrhea, dizziness, bitter taste in the mouth, rash, and constipation. Subjects were seen again 4 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT. Patients were encouraged, but not required, to undergo tongue and fecal flora testing before and after H. pylori eradication to determine the short-term effects of different doses of amoxicillin in combination with keverprazan for 14 days on the patient's tongue and intestinal flora.

Being tested
Keverprazan, Amoxicillin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KeverprazanDrug

    Also called Potassium-competitive acid blocker

    Potassium-competitive acid blocker

  • AmoxicillinDrug

    Also called Antibiotic for H. pylori eradication

    Antibiotic for H. pylori eradication

Study groups in NCT06412640
Study groupRoleWhat they receive
high dose amoxicillin with keverprazan groupActive comparatorPatients need to take keverprazan 20mg bid and amoxicillin 1000mg tid for 14 days.
Receives: Drug: Keverprazan; Drug: Amoxicillin
low dose amoxicillin with keverprazan groupExperimentalPatients need to take keverprazan 20mg bid and amoxicillin 1000mg bid for 14 days.
Receives: Drug: Keverprazan; Drug: Amoxicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at least four weeks after completion of the medication

Secondary outcomes (2)

  1. Adverse even

    Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.

    Measured: Within 7 days after completion of therapy

  2. Compliance Rate

    Compliance was defined as poor when they had taken less than 80% of the total medication

    Measured: Within 7 days after completion of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06412640
Sponsor's protocol ID
KY20240419-15
Status last verified
May 2024
First submitted
9 May 2024
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37086739

  • 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.

    PubMed 36690433

  • 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 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.

    PubMed 35944925

  • 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.

    PubMed 35466521

  • 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.

    PubMed 37533172

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Keverprazan and Amoxicillin in people with H. Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhenyu Zhang (+86 025-87726248, zzy6565@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Helicobacter pylori eradication rate (time frame: at least four weeks after completion of the medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06412640, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

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