Steroids in Fulminant Hepatitis A in the Pediatric Age Group
NCT ID: NCT02375867
Last Updated: 2018-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
33 participants
INTERVENTIONAL
2015-01-31
2017-09-30
Brief Summary
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Detailed Description
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Liver 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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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prednisolone
This group includes patients with FHF without encephalopathy
prednisolone
Oral administration of 1 mg/Kg/day
methylprednisolone
This group includes patients with FHF with encephalopathy
methylprednisolone
Intravenous injection of 0.8 mg/kg/day
Non-intervention
FHF patients without any of the proposed intervention as controls
No interventions assigned to this group
Interventions
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prednisolone
Oral administration of 1 mg/Kg/day
methylprednisolone
Intravenous injection of 0.8 mg/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Evidence of liver dysfunction within 8 weeks of onset of symptoms (neonates may have only deranged liver functions without overt symptoms).
2. 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.
3. No evidence of chronic liver disease.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Quesna Central Hospital, Ministry Of Health, Egypt
UNKNOWN
National Liver Institute, Egypt
OTHER
Responsible Party
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Mostafa M. Sira
Associate Professor of Pediatric Hepatology
Principal Investigators
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Hanaa El-Araby, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pediatric Hepatology Department, National Liver Institute, Egypt
Mostafa M Sira, M.D.
Role: STUDY_DIRECTOR
Pediatric Hepatology Department, National Liver Institute, Egypt
Haydi M Zakaria, M.Sc.
Role: STUDY_CHAIR
Quesna Central Hospital, Ministry Of Health, Egypt
Tahany A Salem, M.Sc.
Role: STUDY_CHAIR
Pediatric Hepatology Department, National Liver Institute, Egypt
Locations
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National Liver Institute
Menoufia, Menoufia, Egypt
Countries
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References
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Cochran JB, Losek JD. Acute liver failure in children. Pediatr Emerg Care. 2007 Feb;23(2):129-35. doi: 10.1097/PEC.0b013e3180308f4b.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NLI-FHF-S-PED
Identifier Type: -
Identifier Source: org_study_id