Helicobacter PyloriNCT06851468
Keverprazan Combined With Amoxicillin for the Treatment of Helicobacter Pylori
A study testing Keverprazan, Esomeprazole and Amoxicillin in people with Helicobacter Pylori, run by Key Laboratory for Gastrointestinal Diseases of Gansu Province at 1 site in China.
Trial summary
The objective of this clinical trial is to determine whether the interventional behavioral drug Keverprazan in combined with amoxicillin, is effective in treating initial Helicobacter pylori infections in adults and to assess the safety of Keverprazan in the treatment of Helicobacter pylori. 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, Esomeprazole and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 1)18~65 years old, gender is not limited;
- 2) H. pylori infection was diagnosed by urea breath test;
- 3) Did not receive H. pylori eradication therapy;
- 4) Informed and consented to participate in this study.
Who cannot join
- 1) Have serious systemic diseases, major organs such as heart, lung, brain diseases, liver and kidney insufficiency, malignant tumors or other diseases;
- 2) Active peptic ulcer with bleeding, perforation, obstruction, cancer and other complications; And subjects with a past or current history of Zolling-Ellison syndrome's disorders;
- 3) Allergic history of penicillin and regimen related drugs;
- 4) Excessive acid-suppressing drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, etc. were used within 2 weeks before enrollment, or antibiotics were used 4 weeks before enrollment;
- 5) Pregnant or lactating women;
- 6) Other participants were deemed unsuitable by the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Keverprazan in Treating H. Pylori：A Randomized Controlled, Multicenter,Prospective Clinical Study
The objective of this clinical trial is to determine whether the interventional behavioral drug Keverprazan in combined with amoxicillin, is effective in treating initial Helicobacter pylori infections in adults and to assess the safety of Keverprazan in the treatment of Helicobacter pylori.
The primary questions it aims to address are:
Read more
- What is the eradication rate of Keverprazan in individuals with the first-time H. pylori infection?
- What adverse effects do participants experience while taking the drug Keverprazan?
- To clarify the microecological changes of Keverprazan on the intestinal tract. The researchers will compare the experimental group receiving Keverprazan in combination with amoxicillin dual therapy to the control group receiving Esomeprazole in combination with amoxicillin dual therapy to assess the efficacy and safety of Keverprazan in treating the primary population infected with Helicobacter pylori.
Participants will:
- Take Keverprazan, esomeprazole, and amoxicillin daily for 14 days;
- Researchers will record participants' medication adherence on days 7 and 14, as well as any adverse drug reactions;
- Participants will undergo a urea breath test one month after discontinuing the medication, and the researchers will record the eradication rate.
- 20 Participants in the experimental group and the control group were randomly selected to collect stool for examination 1 month before and 1 month after treatment.
Read the detailed description
Objective: To analyze the clinical effect of keplasen therapy in treating patients with Helicobacter pylori (Hp) infection.
Methods: Participants who were diagnosed with initial Hp infection by 13C/14C-urea breath test (13C/14C-UBT) test at the The First Hospital of Lanzhou University, People's Hospital of Dingxi City and People's Hospital of Tanchang County from March 2025 onwards were selected as the study subjects.
- Content of the study
- Formulate inclusion and exclusion criteria for Helicobacter pylori infection for the first time, conduct screening, and sign Informed consent.
- The first-time H. pylori infected participants were randomized to the above Keverprazan's group and Esomeprazole's group, and were treated for 14 consecutive days. The urea breath test was repeated 1 month after the end of treatment; during the trial period, the Participants were followed up for drug taking, occurrence of adverse reactions, and review results, to understand the efficacy, safety, and adherence of the combination regimen of Keverprazan and amoxicillin in the treatment of H. pylori infection in the first-treatment population.
- Before and 1 month after the treatment, 20 participants were randomly selected from each group and their feces were collected and sent for examination to summarize the intestinal microecological changes before and after the treatment.
- Sample size estimation The aim of this study was to validate the non-inferiority of the Keverprazan combination regimen in eradicating H. pylori in first-treatment Participants. Since the review of the previous literature did not reveal any four-or two-combination regimens based on Keverprazan for the treatment of Hp infections, and since Keverprazan belongs to the same novel P-CAB as Vonoprazan, the eradication rate in the Keverprazan's group was estimated to be the same as that in the previous study of Vonoprazan at 90.2%, and that in the Esomeprazole's group at 88.5%, with the non-inferiority margin at 10%, α=0.025, and α=0.025. , α=0.025 (unilateral), and 1-β=0.80, the appropriate sample size was calculated to be 110 cases in each group; assuming a 20% loss-to-follow-up rate, the sample size was 132 cases in each group.
- Randomization and blinding Subjects were determined to have or not to have H. pylori infection by urea breath test, and those with primary treatment for H. pylori infection were randomized into separate groups. The Participants primed for H. pylori infection were divided equally into two groups, experimental and control, by randomized numerical table method 1:1, Keverprazan's group- (Keverprazan 20mg Bid + Amoxicillin 1g Tid, 14d), Esomeprazole's group- (Esomeprazole 40mg Bid + Amoxicillin 1g Tid, 14d).
- Follow-up cycle
- First follow-up: on the 7th day after treatment, the occurrence of adverse reactions and compliance of Participants were recorded;
- The second follow-up: on the 14th day of treatment, the occurrence of adverse reactions and compliance were recorded;
- Third follow-up: 1 month after stopping the drug, review the urea breath test at 1 month after stopping the drug, record the occurrence of adverse reactions and compliance of Participants;
- Outcome indicators
- H.pylori eradication rate: 1 month after the end of treatment, review the urea breath test, the result of negative is judged to be successful eradication, positive is judged to be eradication failure.
- Incidence of adverse reactions: Follow-up with the subjects by telephone or WeChat, and record any adverse reactions during the treatment, such as abdominal pain, bloating, diarrhea, constipation, nausea, vomiting, rash, loss of appetite, dry mouth, bitter mouth, fatigue, belching, halitosis, dizziness, headache, and so on;and according to the impact of adverse reactions on daily life, it is divided into "Mild (adverse drug reactions, transient, tolerable, and do not affect daily life)", "Moderate (adverse reactions can cause psychological or physiological discomfort, partially affecting daily life)", "Severe (discomfort degree is heavy, daily life can not be carried out normally)".
- Medication adherence: the rate of medication taken by the subjects during the treatment period, the proportion of the actual amount of medication taken by the Participants to the total amount of medication that should have been taken during the 14-day treatment period, was measured by counting the number of tablets, and those who completed at least 80% of the tablets that should have been taken were considered to be well adhered to, while those who completed less than 80% were considered to be poorly adhered to.
- Factors influencing eradication rates.
- Conditions
- Helicobacter Pylori
- Being tested
- Keverprazan, Esomeprazole, Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeverprazanDrug
Keverprazan ：Dosage form: tablet；dose：20mg；dosage: 2 times a day；duration: 14 days
EsomeprazoleDrug
Esomeprazole：Dosage form: capsule；dose：40mg；dosage: 2 times a day；duration: 14 days
AmoxicillinDrug
Amoxicillin：Dosage form: capsule；dose：1g；dosage: 3 times a day；duration: 14 days。
| Study group | Role | What they receive |
|---|---|---|
| Keverprazan combined with amoxicillin | Experimental | Drug：Keverprazan、Dosage form: tablet, dose: 20mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days； Receives: Drug: Keverprazan; Drug: Amoxicillin |
| Esomeprazole combined with amoxicillin | Active comparator | Drug：Esomeprazole、Dosage form: capsule, dose: 40mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days； Receives: Drug: Esomeprazole; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment eradication rate of primary treatment participants
If the 13C/14C-UBT test of the initial treatment participants was negative at 1 month after 14 days of treatment, the eradication was successful
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start15 Mar 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Key Laboratory for Gastrointestinal Diseases of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Ren, doctorate, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851468
- Sponsor's protocol ID
- MZLKPZ001
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Keverprazan in Treating H. Pylori：A Randomized Controlled, Multicenter,Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06851468
- Acronym / sponsor ID
- MZLKPZ001
- Conditions
- Helicobacter Pylori
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Key Laboratory for Gastrointestinal Diseases of Gansu ProvinceUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 28 Feb 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.
The objective of this clinical trial is to determine whether the interventional behavioral drug Keverprazan in combined with amoxicillin, is effective in treating initial Helicobacter pylori infections in adults and to assess the safety of Keverprazan in the treatment of Helicobacter pylori.
The primary questions it aims to address are:
- What is the eradication rate of Keverprazan in individuals with the first-time H. pylori infection?
- What adverse effects do participants experience while taking the drug Keverprazan?
- To clarify the microecological changes of Keverprazan on the intestinal tract. The researchers will compare the experimental group receiving Keverprazan in combination with amoxicillin dual therapy to the control group receiving Esomeprazole in combination with amoxicillin dual therapy to assess the efficacy and safety of Keverprazan in treating the primary population infected with Helicobacter pylori.
Participants will:
- Take Keverprazan, esomeprazole, and amoxicillin daily for 14 days;
- Researchers will record participants' medication adherence on days 7 and 14, as well as any adverse drug reactions;
- Participants will undergo a urea breath test one month after discontinuing the medication, and the researchers will record the eradication rate.
- 20 Participants in the experimental group and the control group were randomly selected to collect stool for examination 1 month before and 1 month after treatment.
Detailed description
Objective: To analyze the clinical effect of keplasen therapy in treating patients with Helicobacter pylori (Hp) infection.
Methods: Participants who were diagnosed with initial Hp infection by 13C/14C-urea breath test (13C/14C-UBT) test at the The First Hospital of Lanzhou University, People's Hospital of Dingxi City and People's Hospital of Tanchang County from March 2025 onwards were selected as the study subjects.
- Content of the study
- Formulate inclusion and exclusion criteria for Helicobacter pylori infection for the first time, conduct screening, and sign Informed consent.
- The first-time H. pylori infected participants were randomized to the above Keverprazan's group and Esomeprazole's group, and were treated for 14 consecutive days. The urea breath test was repeated 1 month after the end of treatment; during the trial period, the Participants were followed up for drug taking, occurrence of adverse reactions, and review results, to understand the efficacy, safety, and adherence of the combination regimen of Keverprazan and amoxicillin in the treatment of H. pylori infection in the first-treatment population.
- Before and 1 month after the treatment, 20 participants were randomly selected from each group and their feces were collected and sent for examination to summarize the intestinal microecological changes before and after the treatment.
- Sample size estimation The aim of this study was to validate the non-inferiority of the Keverprazan combination regimen in eradicating H. pylori in first-treatment Participants. Since the review of the previous literature did not reveal any four-or two-combination regimens based on Keverprazan for the treatment of Hp infections, and since Keverprazan belongs to the same novel P-CAB as Vonoprazan, the eradication rate in the Keverprazan's group was estimated to be the same as that in the previous study of Vonoprazan at 90.2%, and that in the Esomeprazole's group at 88.5%, with the non-inferiority margin at 10%, α=0.025, and α=0.025. , α=0.025 (unilateral), and 1-β=0.80, the appropriate sample size was calculated to be 110 cases in each group; assuming a 20% loss-to-follow-up rate, the sample size was 132 cases in each group.
- Randomization and blinding Subjects were determined to have or not to have H. pylori infection by urea breath test, and those with primary treatment for H. pylori infection were randomized into separate groups. The Participants primed for H. pylori infection were divided equally into two groups, experimental and control, by randomized numerical table method 1:1, Keverprazan's group- (Keverprazan 20mg Bid + Amoxicillin 1g Tid, 14d), Esomeprazole's group- (Esomeprazole 40mg Bid + Amoxicillin 1g Tid, 14d).
- Follow-up cycle
- First follow-up: on the 7th day after treatment, the occurrence of adverse reactions and compliance of Participants were recorded;
- The second follow-up: on the 14th day of treatment, the occurrence of adverse reactions and compliance were recorded;
- Third follow-up: 1 month after stopping the drug, review the urea breath test at 1 month after stopping the drug, record the occurrence of adverse reactions and compliance of Participants;
- Outcome indicators
- H.pylori eradication rate: 1 month after the end of treatment, review the urea breath test, the result of negative is judged to be successful eradication, positive is judged to be eradication failure.
- Incidence of adverse reactions: Follow-up with the subjects by telephone or WeChat, and record any adverse reactions during the treatment, such as abdominal pain, bloating, diarrhea, constipation, nausea, vomiting, rash, loss of appetite, dry mouth, bitter mouth, fatigue, belching, halitosis, dizziness, headache, and so on;and according to the impact of adverse reactions on daily life, it is divided into "Mild (adverse drug reactions, transient, tolerable, and do not affect daily life)", "Moderate (adverse reactions can cause psychological or physiological discomfort, partially affecting daily life)", "Severe (discomfort degree is heavy, daily life can not be carried out normally)".
- Medication adherence: the rate of medication taken by the subjects during the treatment period, the proportion of the actual amount of medication taken by the Participants to the total amount of medication that should have been taken during the 14-day treatment period, was measured by counting the number of tablets, and those who completed at least 80% of the tablets that should have been taken were considered to be well adhered to, while those who completed less than 80% were considered to be poorly adhered to.
- Factors influencing eradication rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keverprazan combined with amoxicillin | Experimental | Drug: Keverprazan, Drug: AmoxicillinDrug：Keverprazan、Dosage form: tablet, dose: 20mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days； |
| Esomeprazole combined with amoxicillin | Active comparator | Drug: Esomeprazole, Drug: AmoxicillinDrug：Esomeprazole、Dosage form: capsule, dose: 40mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days； |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1)18~65 years old, gender is not limited;
- 2) H. pylori infection was diagnosed by urea breath test;
- 3) Did not receive H. pylori eradication therapy;
- 4) Informed and consented to participate in this study.
Key exclusion criteria (6 listed)
- 1) Have serious systemic diseases, major organs such as heart, lung, brain diseases, liver and kidney insufficiency, malignant tumors or other diseases;
- 2) Active peptic ulcer with bleeding, perforation, obstruction, cancer and other complications; And subjects with a past or current history of Zolling-Ellison syndrome's disorders;
- 3) Allergic history of penicillin and regimen related drugs;
- 4) Excessive acid-suppressing drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, etc. were used within 2 weeks before enrollment, or antibiotics were used 4 weeks before enrollment;
- 5) Pregnant or lactating women;
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 |
|---|---|---|
| KeverprazanKeverprazan ：Dosage form: tablet；dose：20mg；dosage: 2 times a day；duration: 14 days | Drug | Keverprazan combined with amoxicillin |
| EsomeprazoleEsomeprazole：Dosage form: capsule；dose：40mg；dosage: 2 times a day；duration: 14 days | Drug | Esomeprazole combined with amoxicillin |
| AmoxicillinAmoxicillin：Dosage form: capsule；dose：1g；dosage: 3 times a day；duration: 14 days。 | Drug | Esomeprazole combined with amoxicillin, Keverprazan combined with amoxicillin |
Primary outcome
Post-treatment eradication rate of primary treatment participants
Time frame: up to 2 months
If the 13C/14C-UBT test of the initial treatment participants was negative at 1 month after 14 days of treatment, the eradication was successful
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Qian Ren, doctorate principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keverprazan, Esomeprazole and Amoxicillin in people with Helicobacter Pylori, run by Key Laboratory for Gastrointestinal Diseases of Gansu Province 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Apr 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment eradication rate of primary treatment participants (time frame: up to 2 months). 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 29 Apr 2026.