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Steroids in Fulminant Hepatitis A in the Pediatric Age Group

NCT02375867 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-12-17

No results posted yet for this study

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.

Conditions

  • Fulminant Hepatic Failure

Interventions

DRUG

prednisolone

Oral administration of 1 mg/Kg/day

DRUG

methylprednisolone

Intravenous injection of 0.8 mg/kg/day

Sponsors & Collaborators

  • Quesna Central Hospital, Ministry Of Health, Egypt

    collaborator UNKNOWN

  • National Liver Institute, Egypt

    lead OTHER

Principal Investigators

  • Hanaa El-Araby, M.D. · Pediatric Hepatology Department, National Liver Institute, Egypt

  • Mostafa M Sira, M.D. · Pediatric Hepatology Department, National Liver Institute, Egypt

  • Haydi M Zakaria, M.Sc. · Quesna Central Hospital, Ministry Of Health, Egypt

  • Tahany A Salem, M.Sc. · Pediatric Hepatology Department, National Liver Institute, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-08-31
Completion
2017-09-30

Countries

  • Egypt

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02375867 on ClinicalTrials.gov