Skip to main content
OpenTrials
Completed

NCT Number: NCT02375867

Steroids in Fulminant Hepatitis A in the Pediatric Age Group

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Liver Institute

Menoufia, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Evidence of liver dysfunction within 8 weeks of onset of symptoms (neonates may have only deranged liver functions without overt symptoms).
  • 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.
  • No evidence of chronic liver disease.

Exclusion criteria

  • 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).

Treatment and study plan

Prednisolone

Drug

Oral administration of 1 mg/Kg/day

Other names: Hostacortin-H

methylprednisolone

Drug

Intravenous injection of 0.8 mg/kg/day

Other names: Solumedrol

Primary outcomes

  1. Side effect 1 Number of patients with anaphylaxis

    Time frame: 2 months

    Number of patients with anaphylaxis

  2. Side effect 2 Number of patients with angioedema

    Time frame: 2 months

    Number of patients with angioedema

  3. Side effect 3 Number of patients with cardiac arrest

    Time frame: 2 months

    Number of patients with cardiac arrest

  4. Side effect 4 Number of patients with arrhythmias

    Time frame: 2 months

    Number of patients with arrhythmias

  5. Side effect 5 Number of patients with circulatory collapse

    Time frame: 2 months

    Number of patients with circulatory collapse

  6. Side effect 6 Number of patients with congestive heart failure

    Time frame: 2 months

    Number of patients with congestive heart failure

  7. Side effect 7 Number of patients with pulmonary edema

    Time frame: 2 months

    Number of patients with pulmonary edema

  8. Side effect 8 Number of patients with pancreatitis

    Time frame: 2 months

    Number of patients with pancreatitis

Secondary outcomes

  1. Efficacy 1 Number of survivors

    Time frame: 2 months

    number of living patients

  2. Efficacy 2 Number of deaths

    Time frame: 2 months

    number of died patients

  3. Efficacy 3 serum prothrombin time

    Time frame: 72 hour

    serum prothrombin time

  4. Efficacy 3 grade of encephalopathy

    Time frame: 72 hour

    grade of encephalopathy

  5. Efficacy 4 duration of encephalopathy

    Time frame: 2 months

    duration of encephalopathy

Sponsors and collaborators

Lead sponsor

National Liver Institute, Egypt

Other

Collaborators

  • Quesna Central Hospital, Ministry Of Health, Egypt

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2015
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.