Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT01245257
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2010-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-09', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-19', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Hepatic Nitrogen Clearance', 'timeFrame': 'At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment'}], 'secondaryOutcomes': [{'measure': 'Clinical and biochemical measures of inflammation', 'timeFrame': 'At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammation', 'Urea Synthesis', 'Catabolism', 'Nitrogen balance'], 'conditions': ['Alcoholic Hepatitis']}, 'descriptionModule': {'briefSummary': 'Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. The liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.\n\nThe purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with alcoholic hepatitis admitted to hospital for treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alcoholic hepatitis (alcohol intake (\\> 40g/day in 6 months), bilirubin \\> 80 μmol/l)\n\nExclusion Criteria:\n\n* Severe bacterial infections\n* Other chronical inflammatory diseases\n* Cancer\n* Other catabolic diseases\n* Treatment with prednisolone or pentoxifylline within the last 8 weeks'}, 'identificationModule': {'nctId': 'NCT01245257', 'briefTitle': 'Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis', 'orgStudyIdInfo': {'id': 'FHNC-Alk-Hep'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alcoholic Hepatitis', 'description': 'Patients with alcoholic hepatitis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Medicine V, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Karen Louise Thomsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}