Helicobacter Pylori InfectionEarly Phase 1NCT06777732
The Efficacy and Safety of Keverprazan for Helicobacter Pylori Eradication
A Early Phase 1 study testing Keverprazan, Amoxicillin and Furazolidone in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
The purpose of this study was to compare the efficacy of 14-day eradication of Helicobacter pylori with different doses of Keverprazan combined with Amoxicillin dual therapy and Keverprazan-based bismuth quadruple therapy and compare the adverse reactions, compliance, and factors affecting the efficacy of eradication… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Keverprazan, Amoxicillin and Furazolidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 672 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Jan 2026
- Phase
- Early Phase 1
- 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
- Ages 18-65
- Patients who tested positive for H. pylori by 13C or 14C breath test and have not received previous eradication therapy
- Voluntarily join the trial and sign the informed consent form.
Who cannot join
- Allergic to the study drug (e.g. penicillin allergy)
- Recent bleeding or within 4 weeks of bleeding history in the stomach or duodenum
- Patients who have previously received eradication therapy for Helicobacter pylori
- Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study
- Patients who have had surgery on the stomach or intestines, which affects the drug's metabolism
- Pregnant or lactating women
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- Patients with other serious physiological or psychological conditions, or those with liver or kidney dysfunction
- Patients with Zollinger-Ellison syndrome, gastric mucosal-associated lymphoid tissue lymphoma (MALT), or malignant tumors
- Patients with glucose-6-phosphate dehydrogenase (G-6PD) deficiency, peptic ulcer disease, or bronchial asthma
- Patients with concomitant medications including azatanavir or lopinavir, tricyclic antidepressants, levodopa, paracetamol, codeine phosphate/dextromethorphan, monoamine oxidase inhibitors, tramadol, etc.
- Other factors that the investigator considers unsuitable for participation in the study, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy and Safety of Different Doses of Keverprazan Dual Therapy and Keverprazan-Based Bismuth Quadruple Therapy for Eradicating Helicobacter Pylori Infection: a Multicenter, Open, Randomized Controlled Study
The purpose of this study was to compare the efficacy of 14-day eradication of Helicobacter pylori with different doses of Keverprazan combined with Amoxicillin dual therapy and Keverprazan-based bismuth quadruple therapy and compare the adverse reactions, compliance, and factors affecting the efficacy of eradication schemes among different groups.
Read the detailed description
Helicobacter pylori infection is a major cause of gastrointestinal diseases, including peptic ulcers, chronic active gastritis, gastric mucosa-associated lymphoid tissue lymphoma, and fatal stomach cancer. At present, the infection rate of Helicobacter pylori in China is as high as 40.66%, and patients are often accompanied by a variety of upper digestive tract diseases, and about 1% of patients will develop malignant tumors. The Kyoto Global Consensus on Helicobacter Pylori Gastritis emphasizes that Hp gastritis is an infectious disease, HP-associated dyspepsia is an organic disease, and eradication of Hp can be used as a primary preventive measure for gastric cancer.At present, the first-line treatment for Hp eradication is a quadruple regimen of bismuth including proton pump inhibitor (PPI), bismuth agent and two antibacterial agents. However, its radical treatment of Hp still has limitations, mainly including increased side effects related to bismuth use and poor medication compliance. Clarithromycin and metronidazole have high drug resistance and high drug cost. Compared to H. pylori which is highly resistant to clarithromycin and metronidazole, resistance to amoxicillin and furazolidone in China and other countries in the Asia-Pacific region remains low.In recent years, the efficacy of high-dose amoxicillin regimen in eradicating H. pylori has been established, and its eradication rate and adverse reactions are similar to that of bismuth quadruple regimen, with better compliance and lower treatment cost. Potassium competitive acid blocker (P-CAB) is a new generation of acid suppressors. Compared with PPI, P-CAB has stronger acid inhibition effect, rapid onset, no acid activation, no influence of CYP2C19 genotype, long half-life, and better night acid inhibition than PPI.Meta-analyses have shown that P-CAB has a higher Helicobacter pylori eradication rate than PPI (90.2% vs. 75.5%). Keverprazan is a new type of potassium competitive acid blocker, whose acid inhibition is not affected by the environmental PH value, and has a more rapid and sustained acid inhibition effect. Keverprazan 20mg has a stable and lasting inhibitory effect on gastric acid. Several clinical studies have shown that Keverprazan is no less effective than lansoprazole in the treatment of reflux esophagitis and duodenal ulcer. The objective of this study was to evaluate the clinical efficacy of different doses of Keverprazan combined therapy and Keverprazan based bismuth quadruple therapy in the eradication of Helicobacter pylori infection. The three programs were compared from the aspects of eradication rate, compliance, adverse reactions and treatment cost, so as to provide reference and basis for the selection of Hp eradication programs, in order to further improve the effectiveness, safety and economy of Hp eradication and reduce the drug resistance of Hp.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Keverprazan, Amoxicillin, Furazolidone, Colloidal Bismuth Pectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeverprazanDrug
Potassium-competitive acid blocker
AmoxicillinDrug
Antibiotic for H. pylori eradication
FurazolidoneDrug
Antibiotic for H. pylori eradication
Colloidal Bismuth PectinDrug
Gastric mucosal protectant
| Study group | Role | What they receive |
|---|---|---|
| standard dose keverprazan with high dose amoxicillin group | Active comparator | Keverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1000mg tid for 14 days Receives: Drug: Keverprazan; Drug: Amoxicillin |
| low dose keverprazan with high dose amoxicillin group | Experimental | Keverprazan Hydrochloride Tablets 10mg bid and Amoxicillin 1000mg tid for 14 days Receives: Drug: Keverprazan; Drug: Amoxicillin |
| Keverprazan-based bismuth quadruple therapy | Experimental | Keverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1000mg bid and Furazolidone 100mg bid and Colloidal Bismuth Pectin 300mg bid for 14 days Receives: Drug: Keverprazan; Drug: Amoxicillin; Drug: Furazolidone; Drug: Colloidal Bismuth Pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
Measured: Within 7 days after completion of therapy
Secondary outcomes (1)
Helicobacter pylori eradication rate
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Measured: four to six weeks after completion of the medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionJan 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 InfectionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 672 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777732
- Sponsor's protocol ID
- KY20241217-09
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 16 Jan 2025
- 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 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Different Doses of Keverprazan Dual Therapy and Keverprazan-Based Bismuth Quadruple Therapy for Eradicating Helicobacter Pylori Infection: a Multicenter, Open, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06777732
- Acronym / sponsor ID
- KY20241217-09
- Conditions
- Helicobacter Pylori Infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 16 Jan 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 purpose of this study was to compare the efficacy of 14-day eradication of Helicobacter pylori with different doses of Keverprazan combined with Amoxicillin dual therapy and Keverprazan-based bismuth quadruple therapy and compare the adverse reactions, compliance, and factors affecting the efficacy of eradication schemes among different groups.
Detailed description
Helicobacter pylori infection is a major cause of gastrointestinal diseases, including peptic ulcers, chronic active gastritis, gastric mucosa-associated lymphoid tissue lymphoma, and fatal stomach cancer. At present, the infection rate of Helicobacter pylori in China is as high as 40.66%, and patients are often accompanied by a variety of upper digestive tract diseases, and about 1% of patients will develop malignant tumors. The Kyoto Global Consensus on Helicobacter Pylori Gastritis emphasizes that Hp gastritis is an infectious disease, HP-associated dyspepsia is an organic disease, and eradication of Hp can be used as a primary preventive measure for gastric cancer.At present, the first-line treatment for Hp eradication is a quadruple regimen of bismuth including proton pump inhibitor (PPI), bismuth agent and two antibacterial agents. However, its radical treatment of Hp still has limitations, mainly including increased side effects related to bismuth use and poor medication compliance. Clarithromycin and metronidazole have high drug resistance and high drug cost. Compared to H. pylori which is highly resistant to clarithromycin and metronidazole, resistance to amoxicillin and furazolidone in China and other countries in the Asia-Pacific region remains low.In recent years, the efficacy of high-dose amoxicillin regimen in eradicating H. pylori has been established, and its eradication rate and adverse reactions are similar to that of bismuth quadruple regimen, with better compliance and lower treatment cost. Potassium competitive acid blocker (P-CAB) is a new generation of acid suppressors. Compared with PPI, P-CAB has stronger acid inhibition effect, rapid onset, no acid activation, no influence of CYP2C19 genotype, long half-life, and better night acid inhibition than PPI.Meta-analyses have shown that P-CAB has a higher Helicobacter pylori eradication rate than PPI (90.2% vs. 75.5%). Keverprazan is a new type of potassium competitive acid blocker, whose acid inhibition is not affected by the environmental PH value, and has a more rapid and sustained acid inhibition effect. Keverprazan 20mg has a stable and lasting inhibitory effect on gastric acid. Several clinical studies have shown that Keverprazan is no less effective than lansoprazole in the treatment of reflux esophagitis and duodenal ulcer. The objective of this study was to evaluate the clinical efficacy of different doses of Keverprazan combined therapy and Keverprazan based bismuth quadruple therapy in the eradication of Helicobacter pylori infection. The three programs were compared from the aspects of eradication rate, compliance, adverse reactions and treatment cost, so as to provide reference and basis for the selection of Hp eradication programs, in order to further improve the effectiveness, safety and economy of Hp eradication and reduce the drug resistance of Hp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard dose keverprazan with high dose amoxicillin group | Active comparator | Drug: Keverprazan, Drug: AmoxicillinKeverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1000mg tid for 14 days |
| low dose keverprazan with high dose amoxicillin group | Experimental | Drug: Keverprazan, Drug: AmoxicillinKeverprazan Hydrochloride Tablets 10mg bid and Amoxicillin 1000mg tid for 14 days |
| Keverprazan-based bismuth quadruple therapy | Experimental | Drug: Keverprazan, Drug: Amoxicillin, Drug: Furazolidone, Drug: Colloidal Bismuth PectinKeverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1000mg bid and Furazolidone 100mg bid and Colloidal Bismuth Pectin 300mg 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 (3 listed)
- Ages 18-65
- Patients who tested positive for H. pylori by 13C or 14C breath test and have not received previous eradication therapy
- Voluntarily join the trial and sign the informed consent form.
Key exclusion criteria (11 listed)
- Allergic to the study drug (e.g. penicillin allergy)
- Recent bleeding or within 4 weeks of bleeding history in the stomach or duodenum
- Patients who have previously received eradication therapy for Helicobacter pylori
- Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study
- Patients who have had surgery on the stomach or intestines, which affects the drug's metabolism
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 |
|---|---|---|
| KeverprazanPotassium-competitive acid blocker | Drug | Keverprazan-based bismuth quadruple therapy, low dose keverprazan with high dose amoxicillin group, standard dose keverprazan with high dose amoxicillin group |
| AmoxicillinAntibiotic for H. pylori eradication | Drug | Keverprazan-based bismuth quadruple therapy, low dose keverprazan with high dose amoxicillin group, standard dose keverprazan with high dose amoxicillin group |
| FurazolidoneAntibiotic for H. pylori eradication | Drug | Keverprazan-based bismuth quadruple therapy |
| Colloidal Bismuth PectinGastric mucosal protectant | Drug | Keverprazan-based bismuth quadruple therapy |
Primary outcome
Adverse event
Time frame: Within 7 days after completion of therapy
Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
1 secondary outcome
Helicobacter pylori eradication rate
Time frame: four to six weeks after completion of the medication
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 16 Jan 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Keverprazan, Amoxicillin and Furazolidone in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Zhenyu Zhang (+86 025-87726248, zzy6565@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: Within 7 days after completion of therapy). 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 16 Jan 2025.