Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.

November 2, 2026 updated by: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

Efficacy and Safety of Keverprazan-minocycline Dual Therapy With Different Treatment Durations Versus Bismuth-based Quadruple Therapy for Helicobacter Pylori Eradication: an Open-label, Multicenter, Randomized, Non-inferiority Trial.

This study aims to compare the efficacy and safety of keverprazan-minocycline dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication, focusing on eradication rates, patient adherence, and the incidence of adverse drug reactions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

612

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-65 years;
  2. Positive H. pylori status confirmed by 13C-urea breath test and no prior history of eradication therapy;
  3. Voluntary participation and provision of written informed consent

Exclusion Criteria:

  1. Allergy to any study medication (e.g., minocycline, keverprazan, amoxicillin);
  2. Confirmed active peptic ulcer disease;
  3. Prior history of H. pylori eradication treatment;
  4. Use of antibiotics or bismuth agents within 4 weeks before treatment initiation, or use of proton pump inhibitors within 2 weeks;
  5. Current use of corticosteroids, nonsteroidal anti-inflammatory drugs, or anticoagulants;
  6. History of esophageal or gastric surgery;
  7. Pregnancy or lactation;
  8. Severe comorbidities, including hepatic, cardiovascular, pulmonary, or renal disease;
  9. Alcohol abuse;
  10. Gastric mucosa-associated lymphoid tissue lymphoma, malignant tumors, peptic ulcer disease, or bronchial asthma;
  11. Concurrent use of specific medications: atazanavir or rilpivirine, tricyclic antidepressants, levodopa, acetaminophen, guaifenesin/dextromethorphan, monoamine oxidase inhibitors, tramadol, or similar agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10-day dual therapy
Drug: Minocycline

100 mg oral capsule, twice daily

Drug: Keverprazan

20 mg oral tablet, twice daily
Experimental: 14-day dual therapy
Drug: Minocycline

100 mg oral capsule, twice daily

Drug: Keverprazan

20 mg oral tablet, twice daily
Active Comparator: 14-day quadruple therapy
Drug: Minocycline

100 mg oral capsule, twice daily

Drug: Keverprazan

20 mg oral tablet, twice daily

Drug: Amoxicillin

1000 mg oral tablet, twice daily

Drug: Colloidal Bismuth Pectin

300 mg oral preparation, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H. pylori eradication rate
Time Frame: 4-6 weeks after completion of the last dose
4-6 weeks after completion of the last dose
Rate of treatment adherence
Time Frame: assessed on day 7，day 10 and day 14 of eradication therapy

follow-up conducted via WeChat or telephone
assessed on day 7，day 10 and day 14 of eradication therapy
Rate of adverse events
Time Frame: assessed on day 7 ,day 10 and day 14 of eradication therapy

follow-up conducted via WeChat or telephone
assessed on day 7 ,day 10 and day 14 of eradication therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

October 18, 2026

First Submitted That Met QC Criteria

October 23, 2026

First Posted (Actual)

October 29, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-32-26-049733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe