Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 1:35 AM
Study NCT ID:
NCT07121205
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Dual Therapy for H. Pylori Eradication (RETRO-HP Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'De-identified clinical data from medical records (e.g., treatment history, adverse events) were stored in encrypted Excel files. No biological samples retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate', 'timeFrame': '4-6 weeks', 'description': 'Comparison of Eradication Rates among Four Different High-Dose Dual Therapies for Helicobacter pylori'}, {'measure': 'Comparison of Eradication Rates Among Four Different High-Dose Dual Therapies for Helicobacter pylori', 'timeFrame': '4-6 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse Events and Compliance', 'timeFrame': '4-6 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'dual therapy'], 'conditions': ['HELICOBACTER PYLORI INFECTIONS']}, 'referencesModule': {'references': [{'pmid': '39924057', 'type': 'BACKGROUND', 'citation': 'Wiklund AK, Santoni G, Yan J, Radkiewicz C, Xie S, Birgisson H, Ness-Jensen E, von Euler-Chelpin M, Kauppila JH, Lagergren J. Risk of Gastric Adenocarcinoma After Eradication of Helicobacter pylori. Gastroenterology. 2025 Aug;169(2):244-250.e1. doi: 10.1053/j.gastro.2025.01.239. Epub 2025 Feb 7.'}, {'pmid': '40624406', 'type': 'BACKGROUND', 'citation': 'Park JY, Georges D, Alberts CJ, Bray F, Clifford G, Baussano I. Global lifetime estimates of expected and preventable gastric cancers across 185 countries. Nat Med. 2025 Sep;31(9):3020-3027. doi: 10.1038/s41591-025-03793-6. Epub 2025 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nHigh-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.\n\nMethods:\n\nA multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.', 'detailedDescription': 'This study is a multicenter, retrospective, observational study utilizing medical records of outpatients who received standard high-dose dual therapy (HDDT) for Helicobacter pylori eradication between January 2022 and January 2025. The aim was to compare the efficacy and adverse event rates of different HDDT regimens.\n\nCollected data included:\n\nBaseline demographics (age, sex, etc.)\n\nMedical/lifestyle history\n\nTreatment regimens\n\nAdverse events\n\nCompliance\n\nAll data were anonymized at collection, and no additional patient contact or information collection was required. Since this study involved only retrospective chart review without new interventions, patient consent was waived by the ethics committee.\n\nTreatment Groups\n\nPatients were categorized based on their actual prescribed regimens:\n\nAmoxicillin + Vonoprazan (10-day course)\n\nAmoxicillin + Vonoprazan (14-day course)\n\nAmoxicillin + Tegoprazan (14-day course)\n\nAmoxicillin + Esomeprazole (14-day course)\n\nThese groups were compared to assess differences in H. pylori eradication rates.\n\nStudy Characteristics No active intervention or real-time questionnaire collection was involved.\n\nComplies with the real-world evidence (RWE) framework for retrospective studies.\n\nPrimary Outcome Eradication rate comparison between HDDT regimens (assessed via modified intention-to-treat analysis).\n\nSecondary Outcomes Adverse event rates across different HDDT regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '(1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.\n\nExclusion Criteria:\n\n* (1) patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments; (2) patients who received treatment regimens that did not conform to the standardized HDDT protocol specified in this study.'}, 'identificationModule': {'nctId': 'NCT07121205', 'acronym': 'RETROHP', 'briefTitle': 'High-Dose Dual Therapy for H. Pylori Eradication (RETRO-HP Study)', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Comparative Analysis of High-Dose Dual Therapies in First-Line Helicobacter Pylori Eradication: A Multicenter Retrospective Study', 'orgStudyIdInfo': {'id': 'KYLL-2025-07-009'}, 'secondaryIdInfos': [{'id': 'KYLL-2025-07-009', 'type': 'OTHER', 'domain': 'Qilu Hospital of Shandong University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'VA-10 day group', 'interventionNames': ['Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required.']}, {'label': 'VA-14 day group', 'interventionNames': ['Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required.']}, {'label': 'TA group', 'interventionNames': ['Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required.']}, {'label': 'EA group', 'interventionNames': ['Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required.']}], 'interventions': [{'name': 'This study is a retrospective study, and all data have been collected in advance with no active intervention required.', 'type': 'OTHER', 'description': 'This study is a retrospective study, and all data have been collected in advance with no active intervention required.', 'armGroupLabels': ['EA group', 'TA group', 'VA-10 day group', 'VA-14 day group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Wenhuaxilu', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liyueyue', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Liyueyue', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}