At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 33 enrolled
Drug / intervention
prednisolone +1 moredrug
Likely dose
prednisolone 1 mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group
In Brief
A Phase 4 clinical trial evaluating prednisolone and methylprednisolone for Fulminant Hepatic Failure. Completed, enrolled 33 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFulminant Hepatic Failure
CountriesEgypt
CollaboratorsQuesna Central Hospital, Ministry Of Health, Egypt
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedMar 2015
Primary CompletionAug 2017
Study CompletionSep 2017
TodayJul 2026
First PostedMar 3, 2015
Enrollment StartJan 1, 2015
Primary CompletionAug 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.3 years ago
Interventions
prednisolonedrug
Oral administration of 1 mg/Kg/day
methylprednisolonedrug
Intravenous injection of 0.8 mg/kg/day