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RecruitingNCT06734260Updated Dec 5, 2025

Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection

A Phase 3 interventional study of Keverprazan Hydrochloride tablets + high dose amoxicillin and Keverprazan Hydrochloride tablets + low dose amoxicillin in Helicobacter Pylori Eradication Rate, sponsored by Eighth Affiliated Hospital, Sun Yat-sen University. Recruiting at 4 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Eighth Affiliated Hospital, Sun Yat-sen University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2024, registered Dec 2024).
  • Started Sep 2024; still recruiting 2 years later.
Phase
Phase 3
Study type
Interventional
Enrollment
477
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Eradication of HP can significantly improve and reduce HP-related diseases. A 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 85%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. High-dose proton pump inhibitors (PPI) combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. However, the acid inhibition effect of PPI mainly depends on the degree of individual metabolism of proton pump,which might influence the eradication effect. Keverprazan, a new competitive potassium acid blocker(P-CAB), is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with PPIs. This study aimed to evaluate two different doses of therapy (1 g b.i.d. vs. 1.0 g t.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of Keverprazan-amoxicillin dual therapy .

02

Conditions studied

  • Helicobacter Pylori Eradication Rate
03

In context

Lead sponsor

Eighth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 10 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Aged 18 to 75 years;
  2. Adult subjects who voluntarily signed written informed consent approved by the ethics committee to consent to participate in this study before the start of any study procedure;
  3. Subjects who can understand and comply with the protocol requirements and agree to attend all study visits;
  4. During the screening phase, patients who were Hp positive and required Hp eradication therapy as judged by the investigator, and patients who had failed Hp eradication for the first time;
  5. Participants agreed to use appropriate medical methods of contraception (except medically sterilized status) during the study.

Exclusion criteria

Exclusion Criteria:

  • 1. Participated in other clinical studies within 4 weeks before screening; 2. Pregnant or lactating women; 3. Known allergy to keverprazan, esomeprazole, penicillins or other beta-lactams, macrolide antibiotics, nitrofuran antibiotics, or bismuth (including any relevant adjuvants). If skin sensitivity testing (skin testing) was required, it was performed at visit 1 according to routine medical practice; 4. Participants had a history of drug (including but not limited to opioids) abuse or alcohol abuse (> 14 units of alcohol per week, 1 unit of alcohol ≈360mL of approximately 5% beer or 45 ml of approximately 40% spirits or 150 ml of approximately 12% wine) in the year before the screening visit; 5. The subjects had Zolie-Ellison syndrome, gastric acid hypersecretion, or a history of gastric acid hypersecretion; 6. The subject has undergone previous surgery or operation that may affect gastric acid secretion or drug absorption, such as subtotal gastrectomy, total gastrectomy, vagotomy, intestinal resection, etc. Simple surgery for perforation, appendectomy, cholecystectomy, and endoscopic resection of benign tumors are acceptable; 7. "Warning" symptoms such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia that might indicate the presence of a malignant GI lesion, unless a malignant lesion was ruled out by endoscopy; 8. A history of malignancy within 5 years before screening (participants were allowed to participate if they had been cured of skin basal cell carcinoma or cervical carcinoma in situ); 9.. Upper gastrointestinal endoscopy showed acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric or duodenal mucosal injury; 10. According to the investigator's judgment, the subject has uncontrolled and unstable liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, hematological, central nervous system or mental diseases, etc., and participating in the study may affect the safety of the subject or the interpretation of the study results; 11. Subjects who plan to be hospitalized for surgical treatment during the study; 12. H2-receptor antagonist or PPI use within 14 days prior to screening 13C-urea breath test; During the screening period, antibiotics, bismuth and some traditional Chinese medicine with antibacterial effect were taken within 28 days before 13C-urea breath test; 13. Abnormal laboratory test results at screening in any of the following: AST > upper limit of normal (ULN); ALT > Upper limit of normal (ULN); Total bilirubin > ULN; creatinine > 1.5 times ULN; 14. The subjects had clinically significant abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions (PVC), second degree or above atrioventricula
05

Study design

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

Study arms

  • Active comparator
    H-KA-dual-14

    14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)

    Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin

  • Experimental
    L-KA-dual-14

    14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral)

    Drug: Keverprazan Hydrochloride tablets + low dose amoxicillin

  • Experimental
    H-KA-dual-10

    10 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)

    Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)

Interventions

  • DrugKeverprazan Hydrochloride tablets + high dose amoxicillin

    Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 14 day

    Also known as: H-KA-14d

  • DrugKeverprazan Hydrochloride tablets + low dose amoxicillin

    Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 2 times/day, oral, for 14 day

    Also known as: L-KA-14d

  • DrugKeverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)

    Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 10 day

    Also known as: H-KA-10d

06

What researchers measure

Primary outcomes

  1. H. pylori eradication rate

    Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure

    Time frame: 6 weeks

Secondary outcomes

  1. Adverse Event

    Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure.

    Time frame: 6 weeks

  2. Medical financial burden

    Medical financial burden;Questionnaire that will be used to assess this outcome measure.

    Time frame: 6 weeks

07

Study locations

4 of 4 sites recruiting
  • The Sixth Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
    Recruiting
  • Puning Overseas Chinese Hospital
    Puning, Guangdong 515300, China
    Recruiting
  • Eighth Affiliated Hospital,Sun Yet-san University
    Shenzhen, Guangdong 518033, China
    Recruiting
  • Xiangyang Hospital of Traditional Chinese Medicine
    Xiangyang, Hubei 441000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — The datasets used and analysed during the current study available from the corresponding author on reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06734260
Lead sponsor
Eighth Affiliated Hospital, Sun Yat-sen University
Responsible party
chenhonglei (Doctor, Eighth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Dec 16, 2024
Start date
Sep 10, 2024
Primary completion
Nov 10, 2025
Completion
Jan 10, 2026 (estimated)
Last update
Dec 5, 2025

Study contacts

Honglei Chen, MD
Contact
chenhlei3@mail.sysu.edu.cn
18138728623
Shanshan Wei, MD
Contact
weishsh7@mail.sysu.edu.cn
18823305248
Shanshan Wei, MD
study chair · The Eighth Affiliated Hospital,sun Yet-san University
Huizhen Xiong
study chair · The Eighth Affiliated Hospital,sun Yet-san University
Meifang Ye
study chair · The Eighth Affiliated Hospital,sun Yet-san University
Jianfeng Zhong
study chair · The Eighth Affiliated Hospital,sun Yet-san University
Wei Liu
study chair · The Eighth Affiliated Hospital,sun Yet-san University
Fang Liu
study chair · The Eighth Affiliated Hospital,sun Yet-san University
Ting Zhou
study chair · The Eighth Affiliated Hospital,sun Yet-san University
Qiucheng Li
study chair · The Eighth Affiliated Hospital,sun Yet-san University

Oversight

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

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