Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-03 @ 10:48 AM
Study NCT ID:
NCT02116556
Status:
UNKNOWN
Last Update Posted:
2016-11-04
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000078262', 'term': 'Rifaximin'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2014-04-15', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Endotoxemia serum levels', 'timeFrame': '90 days', 'description': 'Measurement of serum changes in endotoxemia levels during the rifaximin treatment.'}], 'primaryOutcomes': [{'measure': 'Rate of bacterial infections', 'timeFrame': '90 days', 'description': 'Development of any bacterial infection.'}], 'secondaryOutcomes': [{'measure': 'Rate of Decompensations of Liver Cirrhosis', 'timeFrame': '90 days', 'description': 'Development of any liver cirrhosis decompensations\n\n1. Hepatic Encephalopathy\n2. Acute Kidney Injury (including Hepatorenal Syndrome)\n3. Acute variceal bleeding\n4. Ascites\n5. Death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alcoholic Hepatitis', 'Bacterial Infections', 'Acute-on-Chronic Liver Failure'], 'conditions': ['Alcoholic Hepatitis']}, 'descriptionModule': {'briefSummary': 'Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis.\n\nThe Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.', 'detailedDescription': 'Design: Open multicenter comparative study. A cohort (n = 66) will receive rifaximin (1200 mg / d) for 90 days. Results will be compared with those of a cohort of AAH prospectively included in an observational study. Both groups with a uniform treatment protocol (which includes the administration of corticosteroids and standardized treatment for complications of liver failure). Patients will be monitorized until hospital discharge and a follow-up visit at 7, 30, 45, 60 and 90 days will be performed.\n\nEndpoints:\n\n1. Primary endpoint: Bacterial infections after 90 days.\n2. Secondary endpoints: :\n\n2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥18 and \\<70 years of age.\n* Active alcohol abuse and excessive alcohol consumption prior to admission defined as \\> 50 g per day for men and\\> 40 g per day for women.\n* Jaundice (Bilirubin \\>2 mg/dl) for no more than 3 months.\n* Clinical suspicion of Alcoholic Hepatitis with a modified Maddrey's Discriminant Function \\> 32 points.\n\nExclusion Criteria:\n\n* Hypersensitivity to Rifaximin\n* Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: all conditions evolved into a clinical stage to limit the patient's functional status (eg, heart failure NYHA\\> II, COPD PCO2\\> 50 mmHg or PO2 \\<60 mmHg, stroke or other disabling neurological disease, disabling or uncontrolled oncological conditions, etc ...).\n\nTerminal illness will be defined as any clinical conditions with a survival expectancy less than 3 months\n\n* Hepatocellular carcinoma (previously diagnosed) beyond Milan's criteria.\n* Complete portal vein thrombosis (previously diagnosed).\n* Autoimmune liver disease.\n* Hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV positive).\n* Pregnancy or nursing.\n* Use of Rifaximin during the previous 2 months.\n* Treatment with Pentoxifylline.\n* Lack of informed consent.\n\nRemoval criteria:\n\n* Lack of histological confirmation of Alcoholic Hepatitis during the first 7 days after inclusion.\n\nBecause there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:\n\nHepatocellular damage (eg, hepatocyte ballooning and presence of Mallory-Denk bodies).\n\nInflammatory infiltrate (predominantly polymorphonuclear cells). Pericellular or sinusoidal fibrosis.\n\n* Hepatocellular carcinoma beyond Milan's criteria diagnosed during the first 7 days after inclusion.\n* Complete portal vein thrombosis diagnosed during the first 7 days after inclusion.\n* Protocol violation.\n* Severe adverse event directly related with Rifaximin."}, 'identificationModule': {'nctId': 'NCT02116556', 'acronym': 'RIFA-AAH', 'briefTitle': 'Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study', 'orgStudyIdInfo': {'id': 'RIFA-AAH.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisone', 'description': 'Prednisone PO 40mg/day for 30 days plus standard supportive care measurements', 'interventionNames': ['Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Prednisone plus Rifaximin', 'description': 'Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements', 'interventionNames': ['Drug: Prednisone', 'Drug: Rifaximin']}], 'interventions': [{'name': 'Prednisone', 'type': 'DRUG', 'description': 'Prednisone PO 40mg/day or IV equivalent dosage for 30 days. Patients not responding at 7 days (e.g. Lille Model ≥ 0.45) treatment with Prednisone will be suspended.', 'armGroupLabels': ['Prednisone', 'Prednisone plus Rifaximin']}, {'name': 'Rifaximin', 'type': 'DRUG', 'description': 'Rifaximin PO 1200 mg/day for 90 days', 'armGroupLabels': ['Prednisone plus Rifaximin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Victor Vargas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Internal Medicine Service. Vall d'Hebron Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Hospital de Sant Pau', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}