NCT02375867

Steroids in Fulminant Hepatitis A in the Pediatric Age Group

Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Liver Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 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

• Fulminant Hepatic Failure

Interventions

Type	Name	Description
DRUG	prednisolone	Oral administration of 1 mg/Kg/day
DRUG	methylprednisolone	Intravenous injection of 0.8 mg/kg/day

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-08-01
• Completion: 2017-09-01
• First posted: 2015-03-03
• Last updated: 2018-12-17

Locations

1 site across 1 country: Egypt