Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-03 @ 3:16 AM
Study NCT ID:
NCT07232095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 316}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H. pylori eradication rate', 'timeFrame': '4-6 weeks after treatment completion', 'description': 'Rate of H. pylori successfully eradicated; The confirmation of H. pylori status was evaluated by Urea breath test.'}], 'secondaryOutcomes': [{'measure': 'Patient compliance', 'timeFrame': '1 day after treatment completion', 'description': 'Good compliance was defined as achieving ≥80% of drugs in the regimes and bad compliance was defined as achieving \\<80% of drugs.'}, {'measure': 'Adverse events', 'timeFrame': 'For the 7-day intervention: assessment on Day 3 and Day 7; For the 14-day intervention: assessment on Day 7 and Day 14.', 'description': 'Adverse drug reactions, including the incidence of both overall and serious adverse events, will be assessed using a standardized questionnaire.'}, {'measure': 'Cost-effectiveness ratio', 'timeFrame': '1 day after the procedure', 'description': 'The cost-effectiveness ratio is defined as the total cost per patient for one course of H. pylori eradication treatment divided by the H. pylori eradication rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter Pylori', 'Vonoprazan', 'Amoxicillin', 'Bismuth', 'Eradication'], 'conditions': ['Helicobacter Pylori']}, 'descriptionModule': {'briefSummary': 'The 2024 American College of Gastroenterology (ACG) Clinical Guideline recommends a 14-day vonoprazan-amoxicillin (VA) regimen, consisting of vonoprazan 20 mg twice daily with amoxicillin 1000 mg three times daily, as a first-line treatment for Helicobacter pylori (H. pylori) infection.\n\nOur previous study on regimen optimization showed that vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily or 750 mg four times daily for 10 days achieved satisfactory eradication rates exceeding 90%, with no significant difference between dosing frequencies. However, when the treatment duration was shortened to 7 days, both dosing schedules failed to reach satisfactory eradication rates, indicating a need for further optimization.\n\nBismuth has antibacterial and synergistic properties, such as disrupting bacterial membranes, suppressing protein synthesis, and reducing virulence factor expression. It may enhance the efficacy of antibiotics. Therefore, this study evaluated the efficacy and safety of a 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection.\n\nEligible participants in this study will be randomly assigned to one of the following treatment groups based on a pre-generated randomization sequence:\n\nControl Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VA-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.\n\nExperimental Group: Vonoprazan combined with high-dose amoxicillin and bismuth therapy for 7 days (VAB-7): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily+Bismuth 220mg twice daily.', 'detailedDescription': 'Helicobacter pylori (H. pylori) is a Gram-negative bacterium that chronically colonizes the gastric mucosa, leading to persistent inflammation and mucosal injury. Eradication of H. pylori can prevent the recurrence of peptic ulcers, treat gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and reduce the risk of gastric cancer. However, with the increasing prevalence of antibiotic resistance, eradication rates have gradually declined worldwide, creating an urgent need for more effective, safe, and practical treatment regimens.\n\nIn recent years, vonoprazan, a novel and potent potassium-competitive acid blocker (P-CAB), has emerged as an alternative to conventional proton pump inhibitors (PPIs). Its rapid onset and strong acid suppression provide an ideal environment for amoxicillin to maintain stable bactericidal activity. The vonoprazan-amoxicillin (VA) dual therapy has demonstrated excellent eradication efficacy and safety in several clinical studies and has been recommended by the 2024 American College of Gastroenterology (ACG) Clinical Guideline as a first-line treatment for H. pylori infection.\n\nOur previous multicenter trial on regimen optimization showed that vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily or 750 mg four times daily for 10 days achieved satisfactory eradication rates above 90%, with no significant difference between dosing frequencies. However, shortening the treatment duration to 7 days resulted in slightly lower eradication rates (below 90%), indicating that the shortened regimen may require further optimization to maintain high efficacy.\n\nBismuth compounds exhibit multiple antimicrobial and synergistic effects. They can inhibit H. pylori adhesion to the gastric mucosa, disrupt bacterial membrane integrity, suppress protein synthesis, and reduce the expression of virulence factors. In addition, bismuth enhances the activity of antibiotics such as amoxicillin by reducing bacterial resistance and increasing local drug concentration in the gastric mucosa. Previous studies have shown that 7-day bismuth-containing regimens(with amoxicillin and tetracycline) can achieve comparable eradication rates to 14-day regimens.\n\nThis study was designed to evaluate whether the addition of bismuth could improve the efficacy of a short-course vonoprazan-amoxicillin regimen. Specifically, the trial investigates the 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection.\n\nThis multicenter, randomized, controlled trial aims to compare the efficacy and safety of VAB-7 with the standard 14-day vonoprazan-high-dose amoxicillin dual therapy (VA-14). The primary endpoint is the eradication rate of H. pylori confirmed by a ¹³C-urea breath test performed at least 4 weeks after treatment completion. Secondary outcomes include adverse event rates, patient adherence, and cost-effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 to 70 years, regardless of sex.\n2. Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment.\n3. Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting the indications for eradication therapy in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (China), and willing to receive eradication treatment.\n4. No prior H. pylori eradication therapy.\n5. Written informed consent before participation.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth).\n2. Use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H₂ receptor antagonists, antibiotics, bismuth preparations, or probiotics within 4 weeks before enrollment.\n3. Pregnant or lactating women.\n4. Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period.\n5. Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy.\n6. History of gastric or esophageal surgery.\n7. Any condition or factor that may affect compliance or make it difficult for the subject to complete follow-up as required.'}, 'identificationModule': {'nctId': 'NCT07232095', 'acronym': 'JSHERO4', 'briefTitle': '7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': '7-Day Vonoprazan-High-Dose Amoxicillin-Bismuth Therapy for First-Line Eradication of Helicobacter Pylori: A Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025JSHERO4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7-day Vonoprazan-High-dose Amoxicillin-Bismuth therapy', 'description': 'Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days', 'interventionNames': ['Drug: VAB-7']}, {'type': 'ACTIVE_COMPARATOR', 'label': '14-day Vonoprazan-Amoxicillin dual therapy', 'description': 'Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days', 'interventionNames': ['Drug: VA-14']}], 'interventions': [{'name': 'VAB-7', 'type': 'DRUG', 'description': 'Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days', 'armGroupLabels': ['7-day Vonoprazan-High-dose Amoxicillin-Bismuth therapy']}, {'name': 'VA-14', 'type': 'DRUG', 'description': 'Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days', 'armGroupLabels': ['14-day Vonoprazan-Amoxicillin dual therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Feng Ye, PhD', 'role': 'CONTACT', 'email': 'fengye@njmu.edu.cn', 'phone': '86+13815897873'}], 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Feng Ye, PhD', 'role': 'CONTACT', 'email': 'fengye@njmu.edu.cn', 'phone': '86+13815897873'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Feng Ye', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}