Helicobacter PyloriPhase 4NCT07122024
Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
A Phase 4 study testing Keverprazan 10 days, Keverprazan 14 days and Rabeprazole in people with Helicobacter Pylori, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Keverprazan 10 days, Keverprazan 14 days and Rabeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2024to 30 Dec 2025
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 to 65 years old, regardless of gender;
- H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
- No previous history of H. pylori eradication therapy;
- Subjects able to independently complete the recording of the subject diary card;
- Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.
Who cannot join
- Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;
- Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
- Previous history of esophageal or gastric surgery;
- Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
- Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
- Female participants who are pregnant, breastfeeding;
Show all 9Show fewer
- Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
- Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
- Deemed unsuitable for participation in the study by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
JUN YE
About this study
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.
Read the detailed description
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1. Study duration: Starting from the date of ethics approval and clinical registration completion, the project will last for 1 year. If you agree to participate in this study, you will be assigned to one of the three treatment groups through randomization (with a 33% probability for each group), with 138 subjects in each group.
The study is divided into a screening phase and a treatment phase, with a total of 4 visit points:
Screening period: -7 to 0 days
- Obtain informed consent;
- Collect demographic information and baseline characteristics of the subject;
- Record medical history and current treatment, concomitant medications (including prescription and over-the-counter drugs);
- Vital signs, physical examination;
- H. pylori test;
- Review inclusion and exclusion criteria;
- Eligible subjects will be randomized to receive assigned treatment based on randomization numbers.
Visit period V2 (telephone visit):
K10 group: 10 days (±3 days), K14 group: 14 days (±3 days), R14 group: 14 days (±3 days)
- Vital signs, physical examination;
- Record concomitant medications;
- Record adverse events after medication. Visit period V3: 9 weeks (±7 days)
- Vital signs, physical examination; 2) H. pylori test; 3) Record concomitant medications; 4) Record adverse events after medication.
- Conditions
- Helicobacter Pylori
- Being tested
- Keverprazan 10 days, Keverprazan 14 days, Rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keverprazan 10 daysDrug
Also called Amoxicillin
Keverprazan dual therapy for 10 days (K10 group):
Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.
Keverprazan 14 daysDrug
Also called Amoxicillin
Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
RabeprazoleDrug
Also called Amoxicillin Clarithromycin Colloidal pectin bismuth
Rabeprazole quadruple therapy for 14 days (R14 group): Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Keverprazan Dual Therapy for 10 Days | Experimental | Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days. Receives: Drug: Keverprazan 10 days |
| Keverprazan Dual Therapy for 14 Days | Active comparator | Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days. Receives: Drug: Keverprazan 14 days |
| Rabeprazole Quadruple Therapy for 14 Days | Active comparator | Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days. Receives: Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate 6-8 weeks after the end of eradication treatment
Efficacy Endpoints:
The primary efficacy endpoint is the proportion of subjects achieving successful Helicobacter pylori eradication 6-8 weeks after completion of first-line therapy. Eradication rates will be reported with two-sided 95% confidence intervals (CIs) calculated using the Clopper-Pearson method. Inter-group differences will be estimated along with their 95% CIs using the Miettinen-Nurminen method. Inter-group comparisons will be performed using the chi-square test or Fisher's exact test, as appropriate.
Measured: 8-10weeks
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Through the incidence, severity (per CTCAE v5.0), and drug-drug interactions of adverse events (AEs) occurring from the start of medication until 8 weeks after the end of medication.
Measured: From first dose of study drug until 8 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start19 Feb 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Jun, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- QIN DU, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineJUN YE, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122024
- Sponsor's protocol ID
- Keverprazan Helicobacter pylo
- Other IDs
- FK2024-6926
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol Inclusion/Exclusion Criteria andFinalStudv Results
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
- ClinicalTrials.gov ID
- NCT07122024
- Acronym / sponsor ID
- Keverprazan Helicobacter pylo
- Conditions
- Helicobacter Pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Aug 2025 (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.
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.
Detailed description
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1. Study duration: Starting from the date of ethics approval and clinical registration completion, the project will last for 1 year. If you agree to participate in this study, you will be assigned to one of the three treatment groups through randomization (with a 33% probability for each group), with 138 subjects in each group.
The study is divided into a screening phase and a treatment phase, with a total of 4 visit points:
Screening period: -7 to 0 days
- Obtain informed consent;
- Collect demographic information and baseline characteristics of the subject;
- Record medical history and current treatment, concomitant medications (including prescription and over-the-counter drugs);
- Vital signs, physical examination;
- H. pylori test;
- Review inclusion and exclusion criteria;
- Eligible subjects will be randomized to receive assigned treatment based on randomization numbers.
Visit period V2 (telephone visit):
K10 group: 10 days (±3 days), K14 group: 14 days (±3 days), R14 group: 14 days (±3 days)
- Vital signs, physical examination;
- Record concomitant medications;
- Record adverse events after medication. Visit period V3: 9 weeks (±7 days)
- Vital signs, physical examination; 2) H. pylori test; 3) Record concomitant medications; 4) Record adverse events after medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Keverprazan Dual Therapy for 10 Days | Experimental | Drug: Keverprazan 10 daysKeverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days. |
| Keverprazan Dual Therapy for 14 Days | Active comparator | Drug: Keverprazan 14 daysKeverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days. |
| Rabeprazole Quadruple Therapy for 14 Days | Active comparator | Drug: RabeprazoleRabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18 to 65 years old, regardless of gender;
- H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
- No previous history of H. pylori eradication therapy;
- Subjects able to independently complete the recording of the subject diary card;
- Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.
Key exclusion criteria (9 listed)
- Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;
- Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
- Previous history of esophageal or gastric surgery;
- Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
- Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
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 10 daysAlso: AmoxicillinKeverprazan dual therapy for 10 days (K10 group): Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days. | Drug | Keverprazan Dual Therapy for 10 Days |
| Keverprazan 14 daysAlso: AmoxicillinKeverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days. | Drug | Keverprazan Dual Therapy for 14 Days |
| RabeprazoleAlso: Amoxicillin Clarithromycin Colloidal pectin bismuthRabeprazole quadruple therapy for 14 days (R14 group): Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days. | Drug | Rabeprazole Quadruple Therapy for 14 Days |
Primary outcome
H. pylori eradication rate 6-8 weeks after the end of eradication treatment
Time frame: 8-10weeks
Efficacy Endpoints: The primary efficacy endpoint is the proportion of subjects achieving successful Helicobacter pylori eradication 6-8 weeks after completion of first-line therapy. Eradication rates will be reported with two-sided 95% confidence intervals (CIs) calculated using the Clopper-Pearson method. Inter-group differences will be estimated along with their 95% CIs using the Miettinen-Nurminen method. Inter-group comparisons will be performed using the chi-square test or Fisher's exact test, as appropriate.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug until 8 weeks after last dose
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 14 Aug 2025.
- Individual participant dataSharing planned: Yes. Protocol Inclusion/Exclusion Criteria andFinalStudv Results
Related trials for Helicobacter Pylori
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
Not yet recruiting
Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Helicobacter Pylori
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
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.
QIN DU principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
JUN YE principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Keverprazan 10 days, Keverprazan 14 days and Rabeprazole in people with Helicobacter Pylori, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 9 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 JUN YE (13858168852, wzmcyejun@zju.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 6-8 weeks after the end of eradication treatment (time frame: 8-10weeks). 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 14 Aug 2025.