Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment

Обзор

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.

Подробное описание

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

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.

Вмешательства

• Препарат Keverprazan 10 days
  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.
• Препарат Keverprazan 14 days
  Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
• Препарат Rabeprazole
  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.

Первичные конечные точки

• H. pylori eradication rate 6-8 weeks after the end of eradication treatment [Срок оценки: 8-10weeks]

Вторичные конечные точки (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: From first dose of study drug until 8 weeks after last dose]

Критерии участия

Критерии включения

• Adult patients aged 18 to 65 years old, regardless of gender;
• H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
• No previous history of H. pylori eradication therapy;
• Subjects able to independently complete the recording of the subject diary card;
• Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.

Критерии исключения

• 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;
• Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
• Previous history of esophageal or gastric surgery;
• Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
• 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.);
• Female participants who are pregnant, breastfeeding;
• Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
• Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
• Deemed unsuitable for participation in the study by the investigator for any other reason.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07122024 · Keverprazan Helicobacter pylo · FK2024-6926

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗