Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT02964195
Status:
UNKNOWN
Last Update Posted:
2016-11-16
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 308}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All clinical events', 'timeFrame': '8 weeks', 'description': 'All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.'}], 'secondaryOutcomes': [{'measure': 'All clinical events', 'timeFrame': '6 months', 'description': 'All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death.'}, {'measure': 'Serum endotoxin,', 'timeFrame': '8 weeks, and 6 months'}, {'measure': 'coagulation function', 'timeFrame': '8 weeks, and 6 months'}, {'measure': 'inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta', 'timeFrame': '8 weeks, and 6 months'}, {'measure': 'Glucose breath hydrogen test', 'timeFrame': '8 weeks, and 6 months'}, {'measure': 'changes of intestinal flora', 'timeFrame': '8 weeks, and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cirrhosis', 'Esophageal and Gastric Varices', 'Gastrointestinal Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '20335583', 'type': 'BACKGROUND', 'citation': 'Bass NM, Mullen KD, Sanyal A, Poordad F, Neff G, Leevy CB, Sigal S, Sheikh MY, Beavers K, Frederick T, Teperman L, Hillebrand D, Huang S, Merchant K, Shaw A, Bortey E, Forbes WP. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010 Mar 25;362(12):1071-81. doi: 10.1056/NEJMoa0907893.'}, {'pmid': '17879356', 'type': 'BACKGROUND', 'citation': 'Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.'}, {'pmid': '19344474', 'type': 'BACKGROUND', 'citation': 'Gasbarrini A, Corazza GR, Gasbarrini G, Montalto M, Di Stefano M, Basilisco G, Parodi A, Usai-Satta P, Vernia P, Anania C, Astegiano M, Barbara G, Benini L, Bonazzi P, Capurso G, Certo M, Colecchia A, Cuoco L, Di Sario A, Festi D, Lauritano C, Miceli E, Nardone G, Perri F, Portincasa P, Risicato R, Sorge M, Tursi A; 1st Rome H2-Breath Testing Consensus Conference Working Group. Methodology and indications of H2-breath testing in gastrointestinal diseases: the Rome Consensus Conference. Aliment Pharmacol Ther. 2009 Mar 30;29 Suppl 1:1-49. doi: 10.1111/j.1365-2036.2009.03951.x.'}, {'pmid': '25034836', 'type': 'BACKGROUND', 'citation': 'Hwang JH, Shergill AK, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Early DS, Evans JA, Fanelli RD, Fisher DA, Foley KQ, Fonkalsrud L, Jue T, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Cash BD; American Society for Gastrointestinal Endoscopy. The role of endoscopy in the management of variceal hemorrhage. Gastrointest Endosc. 2014 Aug;80(2):221-7. doi: 10.1016/j.gie.2013.07.023. No abstract available.'}, {'pmid': '23216382', 'type': 'BACKGROUND', 'citation': 'Vlachogiannakos J, Viazis N, Vasianopoulou P, Vafiadis I, Karamanolis DG, Ladas SD. Long-term administration of rifaximin improves the prognosis of patients with decompensated alcoholic cirrhosis. J Gastroenterol Hepatol. 2013 Mar;28(3):450-5. doi: 10.1111/jgh.12070.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.', 'detailedDescription': 'Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.\n\nThe purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 y.o. ≤age≤75 y.o.;\n* Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N-butyl-cyanoacrylate injection).\n\nExclusion Criteria:\n\n* age \\<18 y.o. or age \\> 75 y.o.;\n* Never had the variceal bleeding episode before;\n* Do not have endoscopic treatment;\n* combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);\n* Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)\n* Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.\n* Acute variceal bleeding within 5 days.\n* Use of other antibiotics in the past 2 weeks;\n* Refuse to participate"}, 'identificationModule': {'nctId': 'NCT02964195', 'acronym': 'EoR-GEVB', 'briefTitle': 'Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Hemorrhage: A Multi-center Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CSY-Rifaximin-HXQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifaximin Group', 'description': 'Rifaximin 400 mg bid for 2 month,', 'interventionNames': ['Drug: Rifaximin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine endoscopic treatment without prophylactic use of antibiotics'}], 'interventions': [{'name': 'Rifaximin', 'type': 'DRUG', 'otherNames': ['XIFAXAN'], 'description': 'ALFA WASSERMANN S.p.A.', 'armGroupLabels': ['Rifaximin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoquan HUANG, M.D.', 'role': 'CONTACT', 'email': 'huangxiaoquan1010@aliyun.com', 'phone': '+86-18801733835'}, {'name': 'Shiyao Chen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaoquan HUANG, M.D.', 'role': 'CONTACT', 'email': 'huangxiaoquan1010@aliyun.com', 'phone': '18801733835'}, {'name': 'Shiyao CHEN, M.D.', 'role': 'CONTACT', 'email': 'chen.shiyao@zs-hospital.sh.cn', 'phone': '13601767310'}], 'overallOfficials': [{'name': 'Shiyao CHEN, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Hospital, Fudan University, Shanghai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lanzhou University Second Hospital', 'class': 'OTHER'}, {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shiyao Chen', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}