Steroids in Fulminant Hepatitis A in the Pediatric Age Group

Phase 4

Completed

• Conditions: Fulminant Hepatic Failure
• Interventions: Drug: prednisolone; Drug: methylprednisolone

• Registration Number: NCT02375867
• Lead Sponsor: National Liver Institute, Egypt

Brief 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-14
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-03
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

The patient is diagnosed to have FHF, if he fulfilled all the following 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

1. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
prednisolone	prednisolone	This group includes patients with FHF without encephalopathy
methylprednisolone	methylprednisolone	This group includes patients with FHF with encephalopathy

Primary Outcome Measures

Name	Time	Method
Side effect 8 Number of patients with pancreatitis	2 months	Number of patients with pancreatitis
Side effect 4 Number of patients with arrhythmias	2 months	Number of patients with arrhythmias
Side effect 3 Number of patients with cardiac arrest	2 months	Number of patients with cardiac arrest
Side effect 2 Number of patients with angioedema	2 months	Number of patients with angioedema
Side effect 1 Number of patients with anaphylaxis	2 months	Number of patients with anaphylaxis
Side effect 5 Number of patients with circulatory collapse	2 months	Number of patients with circulatory collapse
Side effect 6 Number of patients with congestive heart failure	2 months	Number of patients with congestive heart failure
Side effect 7 Number of patients with pulmonary edema	2 months	Number of patients with pulmonary edema

Secondary Outcome Measures

Name	Time	Method
Efficacy 1 Number of survivors	2 months	number of living patients
Efficacy 2 Number of deaths	2 months	number of died patients
Efficacy 3 serum prothrombin time	72 hour	serum prothrombin time
Efficacy 3 grade of encephalopathy	72 hour	grade of encephalopathy
Efficacy 4 duration of encephalopathy	2 months	duration of encephalopathy

Trial Locations

Locations (1)

National Liver Institute; 🇪🇬 Menoufia, Egypt