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| ID | Type | Description | Link |
|---|---|---|---|
| FK2024-6926 | Other Grant/Funding Number | Fosun Pharma |
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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.
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
Visit period V2 (telephone visit):
K10 group: 10 days (±3 days), K14 group: 14 days (±3 days), R14 group: 14 days (±3 days)
1) Vital signs, physical examination; 2) H. pylori test; 3) Record concomitant medications; 4) Record adverse events after medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Keverprazan Dual Therapy for 14 Days | Active Comparator | Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keverprazan 10 days | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8-10weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose of study drug until 8 weeks after last dose |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JUN YE | Contact | 13858168852 | wzmcyejun@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| QIN DU | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| JUN YE | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
Protocol Inclusion/Exclusion Criteria andFinalStudv Results
2025.12
Authorization from the PrincipalInvestigator (Pl) of this study is required
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2024 | Jun 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Keverprazan 14 days | Drug | Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days. |
|
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| Rabeprazole | Drug | 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. |
|
|
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |