Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
Phase: PHASE4
Conditions: Helicobacter Pylori
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

 
Efficacy and safety of keverprazan-amoxicillin dual therapy for Helicobacter pylori first-line treatment 
Protocol Number：BW-Z2314   Version Number：1.1 
Version Date: February 19,2024 
 
Efficacy and safety of keverprazan-amoxicillin dual therapy 
for Helicobacter pylori first-line treatment 
 
(Open-label, randomized controlled study) 
(Protocol Number：BW-Z2314) 
 
 
 
Lead Research Site：The Second Affiliated Hospital Zhejiang University School 
of Medicine 
 
Principal Investigator：QIN DU 
                   JUN YE 
 
 
 
 
 
 
Version Number：1.1 
 
 
 
 
 
 

Efficacy and safety of keverprazan-amoxicillin dual therapy for Helicobacter pylori first-line treatment 
Protocol Number：BW-Z2314   Version Number：1.1 
Version Date: February 19,2024 
 
Protocol Summary 
 
Protocol Number 
BW-Z2314 
Protocol Title 
Efficacy and safety of keverprazan-amoxicillin dual 
therapy for Helicobacter pylori first-line treatment 
Version Number 
1.1 
Observation 
Subjects 
Patients with Helicobacter pylori (Hp) infection who 
require eradication therapy 
Study Objective 
To compare with rabeprazole quadruple therapy and 
evaluate the efficacy and safety of different treatment 
durations (10 days, 14 days) of keverprazan combined 
with amoxicillin dual therapy for Hp eradication 
To evaluate the efficacy and safety of keverprazan 
combined with amoxicillin dual therapy of different 
durations (10-day and 14-day) for Hp eradication, in 
comparison with rabeprazole-based quadruple therapy 
Study Design 
Open-label, randomized controlled study 
Total 
Number 
of 
Cases 
414 patients 
Eligibility Criteria / 
Inclusion 
and 
Exclusion 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.; 

Efficacy and safety of keverprazan-amoxicillin dual therapy for Helicobacter pylori first-line treatment 
Protocol Number：BW-Z2314   Version Number：1.1 
Version Date: February 19,2024 
 
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.  
Investigational 
Drugs 
Keverprazan 
Hydrochloride 
Tablets, 
specification: 
10mg/tablet, trade name: Beiwen®, manufacturer: 
Nanjing Co-phine Shenghui Pharmaceutical Co., Ltd. 
Rabeprazole 
Sodium 
Enteric-coated 
Tablets, 
specification: 10mg/tablet, trade name: Pariet® ，
manufacturer: Eisai (China) Pharmaceutical Co., Ltd. 
Treatment 
Protocols 
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 dual therapy for 14 days (K14 group): 
Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 
days. 
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. 
Efficacy Endpoints 
H. pylori eradication rate 6-8 weeks after the end of 
eradication treatment. 

Efficacy and safety of keverprazan-amoxicillin dual therapy for Helicobacter pylori first-line treatment 
Protocol Number：BW-Z2314   Version Number：1.1 
Version Date: February 19,2024 
 
Safety Endpoints 
1) Vital signs, physical examination; 
2) Adverse events and serious adverse events. 
Study Procedures 
Screening period: -7 to 0 days 
1) Obtain informed consent; 
2) Collect demographic information and baseline 
characteristics of the subject; 
3) Record medical history and current treatment, 
concomitant medications (including prescription and 
over-the-counter drugs); 
4) Vital signs, physical examination; 
5) H. pylori test; 
6) Review inclusion and exclusion criteria; 
7) 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) 
1) Vital signs, physical examination; 
2) Record concomitant medications; 
3) Record adverse events after medication. 
Visit period V3: 9 weeks (±7 days) 
1) Vital signs, physical examination; 
2) H. pylori test; 
3) Record concomitant medications; 
4) Record adverse events after medication. 
Statistical Analysis 
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. 
Safety Endpoints: 
Adverse events (AEs) will be coded using the Medical 
Dictionary for Regulatory Activities (MedDRA) and 

Efficacy and safety of keverprazan-amoxicillin dual therapy for Helicobacter pylori first-line treatment 
Protocol Number：BW-Z2314   Version Number：1.1 
Version Date: February 19,2024 
 
summarized by System Organ Class (SOC) and Preferred 
Term (PT). The number of subjects experiencing AEs, 
event counts, and incidence rates will be calculated. 
Between-group comparisons of AE incidence will be 
assessed using Fisher’s exact test. 
Study Duration 
8 to 10 weeks