NCT07122024 Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
| NCT ID | NCT07122024 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Helicobacter Pylori |
| Study Type | INTERVENTIONAL |
| Enrollment | 414 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 414 participants in total. It began in 2024-02-19 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 14 days) at a ratio of 1:1:1.
Eligibility Criteria
Inclusion Criteria 1. Adult patients aged 18 to 65 years old, regardless of gender; 2. H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture; 3. No previous history of H. pylori eradication therapy; 4. Subjects able to independently complete the recording of the subject diary card; 5. Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form. Exclusion Criteria 1. 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; 2. Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.; 3. Previous history of esophageal or gastric surgery; 4. Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases; 5. 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.); 6. Female participants who are pregnant, breastfeeding; 7. Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events; 8. Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators; 9. Deemed unsuitable for participation in the study by the investigator for any other reason.
Contact & Investigator
QIN DU
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT07122024 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Helicobacter Pylori. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07122024 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07122024 currently recruiting?
Yes, NCT07122024 is actively recruiting participants. Contact the research team at wzmcyejun@zju.edu.cn for enrollment information.
Where is the NCT07122024 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07122024 clinical trial?
NCT07122024 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is QIN DU at Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 414 participants.