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RecruitingNCT07904429Updated Oct 29, 2026

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

A Phase 3 interventional study of Minocycline and Keverprazan in Helicobacter Infection, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2026, registered Oct 2026).
  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
612
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Helicobacter Infection

Keywords

  • H. pylori
03

In context

Helicobacter Infections

189 studies on the registry are indexed under Helicobacter Infections; 34 are open to participants now.

This study's planned enrollment of 612 is above the median of 160 across 135 interventional studies indexed under Helicobacter Infections.

Browse Helicobacter Infections studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 224 studies on the registry; 110 are open to participants now.

Browse Nanjing First Hospital, Nanjing Medical University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
612 participants (estimated)

Study arms

  • Experimental
    10-day dual therapy

    Drug: Minocycline · Drug: Keverprazan

  • Experimental
    14-day dual therapy

    Drug: Minocycline · Drug: Keverprazan

  • Active comparator
    14-day quadruple therapy

    Drug: Minocycline · Drug: Keverprazan · Drug: Amoxicillin · Drug: Colloidal Bismuth Pectin

Interventions

06

What researchers measure

Primary outcomes

  1. eradication rates.

    Time frame: 4-6 weeks after completion of the last dose

  2. adherence

    follow-up conducted via WeChat or telephone

    Time frame: assessed on day 7，day 10 and day 14 of eradication therapy

  3. incidence of Adverse Events

    follow-up conducted via WeChat or telephone

    Time frame: assessed on day 7 ,day 10 and day 14 of eradication therapy

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904429
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Zhenyu Zhang (professor, Nanjing First Hospital, Nanjing Medical University) — Principal investigator
First posted
Oct 29, 2026
Start date
Jul 15, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Zhenyu Zhang
Contact
zzy6565@sina.com
18951670222

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Minocycline · Keverprazan

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