Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02375867
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2015-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroids in Fulminant Hepatitis A in the Pediatric Age Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-11', 'size': 2688869, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-11T04:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2015-02-14', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Side effect 1 Number of patients with anaphylaxis', 'timeFrame': '2 months', 'description': 'Number of patients with anaphylaxis'}, {'measure': 'Side effect 2 Number of patients with angioedema', 'timeFrame': '2 months', 'description': 'Number of patients with angioedema'}, {'measure': 'Side effect 3 Number of patients with cardiac arrest', 'timeFrame': '2 months', 'description': 'Number of patients with cardiac arrest'}, {'measure': 'Side effect 4 Number of patients with arrhythmias', 'timeFrame': '2 months', 'description': 'Number of patients with arrhythmias'}, {'measure': 'Side effect 5 Number of patients with circulatory collapse', 'timeFrame': '2 months', 'description': 'Number of patients with circulatory collapse'}, {'measure': 'Side effect 6 Number of patients with congestive heart failure', 'timeFrame': '2 months', 'description': 'Number of patients with congestive heart failure'}, {'measure': 'Side effect 7 Number of patients with pulmonary edema', 'timeFrame': '2 months', 'description': 'Number of patients with pulmonary edema'}, {'measure': 'Side effect 8 Number of patients with pancreatitis', 'timeFrame': '2 months', 'description': 'Number of patients with pancreatitis'}], 'secondaryOutcomes': [{'measure': 'Efficacy 1 Number of survivors', 'timeFrame': '2 months', 'description': 'number of living patients'}, {'measure': 'Efficacy 2 Number of deaths', 'timeFrame': '2 months', 'description': 'number of died patients'}, {'measure': 'Efficacy 3 serum prothrombin time', 'timeFrame': '72 hour', 'description': 'serum prothrombin time'}, {'measure': 'Efficacy 3 grade of encephalopathy', 'timeFrame': '72 hour', 'description': 'grade of encephalopathy'}, {'measure': 'Efficacy 4 duration of encephalopathy', 'timeFrame': '2 months', 'description': 'duration of encephalopathy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fulminant Hepatic Failure']}, 'referencesModule': {'references': [{'pmid': '17351416', 'type': 'BACKGROUND', 'citation': 'Cochran JB, Losek JD. Acute liver failure in children. Pediatr Emerg Care. 2007 Feb;23(2):129-35. doi: 10.1097/PEC.0b013e3180308f4b.'}, {'pmid': '20638564', 'type': 'BACKGROUND', 'citation': 'Bernal W, Auzinger G, Dhawan A, Wendon J. Acute liver failure. Lancet. 2010 Jul 17;376(9736):190-201. doi: 10.1016/S0140-6736(10)60274-7.'}, {'pmid': '21181913', 'type': 'BACKGROUND', 'citation': 'Fujiwara K, Kojima H, Yasui S, Okitsu K, Yonemitsu Y, Omata M, Yokosuka O. Hepatitis A viral load in relation to severity of the infection. J Med Virol. 2011 Feb;83(2):201-7. doi: 10.1002/jmv.21958.'}, {'pmid': '18807133', 'type': 'BACKGROUND', 'citation': 'Fujiwara K, Yasui S, Yonemitsu Y, Fukai K, Arai M, Imazeki F, Suzuki A, Suzuki H, Sadahiro T, Oda S, Yokosuka O. Efficacy of combination therapy of antiviral and immunosuppressive drugs for the treatment of severe acute exacerbation of chronic hepatitis B. J Gastroenterol. 2008;43(9):711-9. doi: 10.1007/s00535-008-2222-5. Epub 2008 Sep 20.'}, {'pmid': '10674400', 'type': 'BACKGROUND', 'citation': 'Lahuna O, Rastegar M, Maiter D, Thissen JP, Lemaigre FP, Rousseau GG. Involvement of STAT5 (signal transducer and activator of transcription 5) and HNF-4 (hepatocyte nuclear factor 4) in the transcriptional control of the hnf6 gene by growth hormone. Mol Endocrinol. 2000 Feb;14(2):285-94. doi: 10.1210/mend.14.2.0423.'}, {'pmid': '18576304', 'type': 'BACKGROUND', 'citation': 'Seshadri R, Feldman BM, Ilowite N, Cawkwell G, Pachman LM. The role of aggressive corticosteroid therapy in patients with juvenile dermatomyositis: a propensity score analysis. Arthritis Rheum. 2008 Jul 15;59(7):989-95. doi: 10.1002/art.23829.'}]}, 'descriptionModule': {'briefSummary': 'Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. Liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it is suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.', 'detailedDescription': 'Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. FHF is the clinical manifestation of liver cell death of a critical degree with insufficient hepatocellular regeneration and characterized by coagulopathy with or without hepatic encephalopathy.\n\nLiver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it was suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patient is diagnosed to have FHF, if he fulfilled all the following criteria:\n\n1. Evidence of liver dysfunction within 8 weeks of onset of symptoms (neonates may have only deranged liver functions without overt symptoms).\n2. Uncorrectable coagulopathy (6-8 hours after administration of one dose of parenteral vitamin K) with International Normalized Ratio (INR) \\>1.5 in patients with hepatic encephalopathy, or INR\\> 2.0 in patients without encephalopathy.\n3. No evidence of chronic liver disease.\n\nExclusion Criteria:\n\n1\\. Presence of absolute contra-indications to steroid therapy (as presence of an active gastrointestinal bleeding, renal failure, acute pancreatitis, active tuberculosis, uncontrolled diabetes and psychosis).'}, 'identificationModule': {'nctId': 'NCT02375867', 'briefTitle': 'Steroids in Fulminant Hepatitis A in the Pediatric Age Group', 'organization': {'class': 'OTHER', 'fullName': 'National Liver Institute, Egypt'}, 'officialTitle': 'Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group', 'orgStudyIdInfo': {'id': 'NLI-FHF-S-PED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'prednisolone', 'description': 'This group includes patients with FHF without encephalopathy', 'interventionNames': ['Drug: prednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'methylprednisolone', 'description': 'This group includes patients with FHF with encephalopathy', 'interventionNames': ['Drug: methylprednisolone']}, {'type': 'NO_INTERVENTION', 'label': 'Non-intervention', 'description': 'FHF patients without any of the proposed intervention as controls'}], 'interventions': [{'name': 'prednisolone', 'type': 'DRUG', 'otherNames': ['Hostacortin-H'], 'description': 'Oral administration of 1 mg/Kg/day', 'armGroupLabels': ['prednisolone']}, {'name': 'methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solumedrol'], 'description': 'Intravenous injection of 0.8 mg/kg/day', 'armGroupLabels': ['methylprednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Menoufia', 'state': 'Menoufia', 'country': 'Egypt', 'facility': 'National Liver Institute'}], 'overallOfficials': [{'name': 'Hanaa El-Araby, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Hepatology Department, National Liver Institute, Egypt'}, {'name': 'Mostafa M Sira, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Hepatology Department, National Liver Institute, Egypt'}, {'name': 'Haydi M Zakaria, M.Sc.', 'role': 'STUDY_CHAIR', 'affiliation': 'Quesna Central Hospital, Ministry Of Health, Egypt'}, {'name': 'Tahany A Salem, M.Sc.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pediatric Hepatology Department, National Liver Institute, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Liver Institute, Egypt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quesna Central Hospital, Ministry Of Health, Egypt', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatric Hepatology', 'investigatorFullName': 'Mostafa M. Sira', 'investigatorAffiliation': 'National Liver Institute, Egypt'}}}}