AzTrials
AzTrials

Helicobacter Pylori Eradication RatePhase 3NCT06734260

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

A Phase 3 study testing Keverprazan Hydrochloride tablets + high dose amoxicillin, Keverprazan Hydrochloride tablets + low dose amoxicillin and Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d) in people with Helicobacter Pylori Eradication Rate, run by Eighth Affiliated Hospital, Sun Yat-sen University at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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%. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Helicobacter Pylori Eradication Rate
What is being tested?
Keverprazan Hydrochloride tablets + high dose amoxicillin, Keverprazan Hydrochloride tablets + low dose amoxicillin and Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
477 participants
Where
4 sitesChina
Study dates
10 Sep 2024to 10 Jan 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years;
  • 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;
  • Subjects who can understand and comply with the protocol requirements and agree to attend all study visits;
  • 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;
  • Participants agreed to use appropriate medical methods of contraception (except medically sterilized status) during the study.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China4 sites, 4 recruiting
  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Xiang Peng, MD, 8618320766916, pengx5@mail.sysu.edu

    Recruiting
  • Puning Overseas Chinese Hospital

    Puning, Guangdong, 515300

    Zhihao Huang, MD, 8613580286843, 108382408@qq.com

    Recruiting
  • Eighth Affiliated Hospital,Sun Yet-san University

    Shenzhen, Guangdong, 518033

    Honglei Chen, MD, 18138728623, chenhlei3@mail.sysu.edu.cn

    Recruiting
  • Xiangyang Hospital of Traditional Chinese Medicine

    Xiangyang, Hubei, 441000

    Jing Zhao, MD, 8615971138823, 42522054@QQ.COM

    Recruiting

Other trials in China

About this study

Official title: Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection:a Multicenter, Prospective, Randomized Controlled Study

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 .

Being tested
Keverprazan Hydrochloride tablets + high dose amoxicillin, Keverprazan Hydrochloride tablets + low dose amoxicillin, Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)

What participants receive

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

  • Keverprazan Hydrochloride tablets + high dose amoxicillinDrug

    Also called H-KA-14d

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

  • Keverprazan Hydrochloride tablets + low dose amoxicillinDrug

    Also called L-KA-14d

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

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

    Also called H-KA-10d

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

Study groups in NCT06734260
Study groupRoleWhat they receive
H-KA-dual-14Active comparator14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)
Receives: Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin
L-KA-dual-14Experimental14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral)
Receives: Drug: Keverprazan Hydrochloride tablets + low dose amoxicillin
H-KA-dual-10Experimental10 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)
Receives: Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)

What is being measured

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

  1. H. pylori eradication rate

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

    Measured: 6 weeks

Secondary outcomes (2)
  1. Adverse Event

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

    Measured: 6 weeks

  2. Medical financial burden

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

    Measured: 6 weeks

Timeline

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

  1. First posted16 Dec 2024
  2. Study start10 Sep 2024
  3. Primary completion10 Nov 2025
  4. Study completion10 Jan 2026 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
477 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06734260
Sponsor's protocol ID
2024-229-02
Status last verified
Nov 2025
First submitted
12 Dec 2024
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets used and analysed during the current study available from the corresponding author on reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Keverprazan Hydrochloride tablets + high dose amoxicillin, Keverprazan Hydrochloride tablets + low dose amoxicillin and Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d) in people with Helicobacter Pylori Eradication Rate, run by Eighth Affiliated Hospital, Sun Yat-sen University at 4 sites in China.

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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Honglei Chen, MD (18138728623, chenhlei3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

H. pylori eradication rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Dec 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in