Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT01897051
Status:
UNKNOWN
Last Update Posted:
2015-04-21
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}, {'id': 'D011433', 'term': 'Propranolol'}], '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'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-19', 'studyFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2013-07-08', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic vein pressure gradient(HVPG)', 'timeFrame': 'Change from baseline heptic vein pressure gradient at 6 weeks', 'description': 'After measurement of baseline HVPG, patients will be randomized to treatment group of Rifaximin + Propranolol or Propranolol + Placebo. And 6 weeks after treatment, follow-up measurement of HVPG will be performed to evaluate efficacy of two regimens'}], 'secondaryOutcomes': [{'measure': 'occurence of gastrointestinal bleeding', 'timeFrame': 'upto 6 months after initiation of treatment', 'description': 'when gastrointestinal bleeding occurs, after initiation of treatment, endoscopy will be performed to evaluate status of bleeding'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver cirrhosis', 'Portal hypertension', 'Hepatic Venous Pressure Gradient', 'Rifaximin'], 'conditions': ['Liver Cirrhosis', 'Portal Hypertension']}, 'referencesModule': {'references': [{'pmid': '12899586', 'type': 'BACKGROUND', 'citation': 'Rasaratnam B, Kaye D, Jennings G, Dudley F, Chin-Dusting J. The effect of selective intestinal decontamination on the hyperdynamic circulatory state in cirrhosis. A randomized trial. Ann Intern Med. 2003 Aug 5;139(3):186-93. doi: 10.7326/0003-4819-139-3-200308050-00008.'}, {'pmid': '19210289', 'type': 'BACKGROUND', 'citation': 'Vlachogiannakos J, Saveriadis AS, Viazis N, Theodoropoulos I, Foudoulis K, Manolakopoulos S, Raptis S, Karamanolis DG. Intestinal decontamination improves liver haemodynamics in patients with alcohol-related decompensated cirrhosis. Aliment Pharmacol Ther. 2009 May 1;29(9):992-9. doi: 10.1111/j.1365-2036.2009.03958.x. Epub 2009 Feb 7.'}, {'pmid': '17006916', 'type': 'BACKGROUND', 'citation': 'Gonzalez A, Augustin S, Perez M, Dot J, Saperas E, Tomasello A, Segarra A, Armengol JR, Malagelada JR, Esteban R, Guardia J, Genesca J. Hemodynamic response-guided therapy for prevention of variceal rebleeding: an uncontrolled pilot study. Hepatology. 2006 Oct;44(4):806-12. doi: 10.1002/hep.21343.'}, {'pmid': '16175621', 'type': 'BACKGROUND', 'citation': 'Ripoll C, Banares R, Rincon D, Catalina MV, Lo Iacono O, Salcedo M, Clemente G, Nunez O, Matilla A, Molinero LM. Influence of hepatic venous pressure gradient on the prediction of survival of patients with cirrhosis in the MELD Era. Hepatology. 2005 Oct;42(4):793-801. doi: 10.1002/hep.20871.'}, {'pmid': '18433395', 'type': 'BACKGROUND', 'citation': 'Kumar M, Kumar A, Hissar S, Jain P, Rastogi A, Kumar D, Sakhuja P, Sarin SK. Hepatic venous pressure gradient as a predictor of fibrosis in chronic liver disease because of hepatitis B virus. Liver Int. 2008 May;28(5):690-8. doi: 10.1111/j.1478-3231.2008.01711.x.'}]}, 'descriptionModule': {'briefSummary': 'To reduce portal pressure, the only recommended medication is nonselective beta blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response rate and compliance.\n\nRecent literature has supported the role of bacterial translocation as a mediator of splanchnic vasodilatation and portal hypertension. This stimulates the release of pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut decontamination with Rifaximin can induce inhibition of bacterial translocation and associated worsening of portal hypertension. The investigators hypothesized that Rifaximin plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal varices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings\n* 19≤age≤75\n* Hepatic venous pressure gradient \\> 12 mmHg\n* Informed consent\n\nExclusion Criteria:\n\n* Shock status requiring vasopressor\n* Active infection, for example Spontaneous bacterial peritonitis\n* Acute renal failure patients of any cause\n* Clinically relevant coronary artery disease(NYHA functional angina classification III/IV),congestive heart failure NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the past 12 months\n* Poorly controlled hypertension (BP 150/100mmHg)\n* Hepatocellular carcinoma\n* History of another primary malignancy ≤ 3years\n* Medical or psychological conditions that would not permit the subject to complete thte study or sign informed consent\n* Pregnancy or lactation period\n* Serum creatinine ≧ 6mg/dL\n* Involvement in the conduct of other study within 30 days\n* Known hypersensitivity to Rifaximin or propranolol\n* Dysarrhythmia, inappropriate for study on investigator's judgment"}, 'identificationModule': {'nctId': 'NCT01897051', 'acronym': 'RECOVER', 'briefTitle': 'Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Hemodynamic Response of Rifaximin and Non-selective β-blocker Combination Therapy Versus Non-selective β-blocker Monotherapy in Cirrhotic Patients With Esophageal Varices', 'orgStudyIdInfo': {'id': 'CR310037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination therapy', 'description': 'Rifaximin(normix®)+nonselective beta-blocker(Propranolol)', 'interventionNames': ['Drug: Rifaximin + propranolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Monotherapy', 'description': 'nonselective beta-blocker(Propranolol) + Placebo(of Rifaximin)', 'interventionNames': ['Drug: Propranolol + Placebo']}], 'interventions': [{'name': 'Rifaximin + propranolol', 'type': 'DRUG', 'otherNames': ['Normix', 'Propranolol'], 'description': '1. Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day)\n2. Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day.\n\n(Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute).\n\nIf patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared.', 'armGroupLabels': ['Combination therapy']}, {'name': 'Propranolol + Placebo', 'type': 'DRUG', 'otherNames': ['Non-selective beta-blocker', 'Placebo of Rifaximin'], 'description': '1. Placebo of Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day)\n2. Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day.\n\n(Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute).\n\nIf patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared.', 'armGroupLabels': ['Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220-701', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Moon Young Kim, MD,PhD', 'role': 'CONTACT', 'email': 'drkimmy@yonsei.ac.kr', 'phone': '82-33-741-1225'}, {'name': 'Moon Young Kim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yonsei University Wonju Severance Cristian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Wŏnju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Moon Young Kim, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'Moon Young Kim, MD,PhD', 'role': 'CONTACT', 'email': 'drkimmy@yonsei.ac.kr', 'phone': '82-33-741-1225'}], 'overallOfficials': [{'name': 'Moon Young Kim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}, {'name': 'Moon Young Kim, M.D., PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Yonsei University Wonhu College of Medicine Wonju Severance Christian Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Divistion of Gastroenterology and Hepatology, Department of Internal Medicine', 'investigatorFullName': 'Moon Young Kim', 'investigatorAffiliation': 'Yonsei University'}}}}