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.
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
- 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
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 .
- Conditions
- Helicobacter Pylori Eradication Rate
- 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 group | Role | What they receive |
|---|---|---|
| H-KA-dual-14 | Active comparator | 14 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-14 | Experimental | 14 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-10 | Experimental | 10 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.
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)
Adverse Event
Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure.
Measured: 6 weeks
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.
- First posted16 Dec 2024
- Study start10 Sep 2024
- Primary completion10 Nov 2025
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Eradication RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chenhonglei, Eighth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Shanshan Wei, MD, Study chair, The Eighth Affiliated Hospital,sun Yet-san UniversityHuizhen Xiong, Study chair, The Eighth Affiliated Hospital,sun Yet-san UniversityMeifang Ye, Study chair, The Eighth Affiliated Hospital,sun Yet-san UniversityJianfeng Zhong, Study chair, The Eighth Affiliated Hospital,sun Yet-san UniversityWei Liu, Study chair, The Eighth Affiliated Hospital,sun Yet-san UniversityFang Liu, Study chair, The Eighth Affiliated Hospital,sun Yet-san UniversityTing Zhou, Study chair, The Eighth Affiliated Hospital,sun Yet-san UniversityQiucheng Li, Study chair, The Eighth Affiliated Hospital,sun Yet-san University
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection:a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06734260
- Acronym / sponsor ID
- 2024-229-02
- Conditions
- Helicobacter Pylori Eradication Rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 477 participants (estimated)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H-KA-dual-14 | Active comparator | Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral) |
| L-KA-dual-14 | Experimental | Drug: Keverprazan Hydrochloride tablets + low dose amoxicillin14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral) |
| H-KA-dual-10 | Experimental | Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)10 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keverprazan Hydrochloride tablets + high dose amoxicillinAlso: H-KA-14dKeverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 14 day | Drug | H-KA-dual-14 |
| Keverprazan Hydrochloride tablets + low dose amoxicillinAlso: L-KA-14dKeverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 2 times/day, oral, for 14 day | Drug | L-KA-dual-14 |
| Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)Also: H-KA-10dKeverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 10 day | Drug | H-KA-dual-10 |
Primary outcome
H. pylori eradication rate
Time frame: 6 weeks
Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure
2 secondary outcomes
Adverse Event
Time frame: 6 weeks
Medical financial burden
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. The datasets used and analysed during the current study available from the corresponding author on reasonable request.
Related trials for Helicobacter Pylori Eradication Rate
RecruitingPhase 4
CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication
H. Pylori Gastrointestinal Disease, H.Pylori Infection
Enrolling by invitation
to Assess the Eradication Rate of 14-day Bismuth/Amoxicillin/PCAB Triple Therapy for the Treatment of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
4 sites in 1 country: see every site and its status.
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.