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Steroids in Fulminant Hepatitis A in the Pediatric Age Group

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ClinicalTrials.gov Identifier: NCT02375867
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
Quesna Central Hospital, Ministry Of Health, Egypt
Information provided by (Responsible Party):
Mostafa M. Sira, 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.

Condition or disease Intervention/treatment Phase
Fulminant Hepatic Failure Drug: prednisolone Drug: methylprednisolone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group
Actual Study Start Date : January 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Active Comparator: prednisolone
This group includes patients with FHF without encephalopathy
Drug: prednisolone
Oral administration of 1 mg/Kg/day
Other Name: Hostacortin-H

Active Comparator: methylprednisolone
This group includes patients with FHF with encephalopathy
Drug: methylprednisolone
Intravenous injection of 0.8 mg/kg/day
Other Name: Solumedrol

No Intervention: Non-intervention
FHF patients without any of the proposed intervention as controls



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375867


Locations
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Egypt
National Liver Institute
Menoufia, Egypt, 32511
Sponsors and Collaborators
National Liver Institute, Egypt
Quesna Central Hospital, Ministry Of Health, Egypt
Investigators
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Principal Investigator: Hanaa El-Araby, M.D. Pediatric Hepatology Department, National Liver Institute, Egypt
Study Director: Mostafa M Sira, M.D. Pediatric Hepatology Department, National Liver Institute, Egypt
Study Chair: Haydi M Zakaria, M.Sc. Quesna Central Hospital, Ministry Of Health, Egypt
Study Chair: Tahany A Salem, M.Sc. Pediatric Hepatology Department, National Liver Institute, Egypt
  Study Documents (Full-Text)

Documents provided by Mostafa M. Sira, National Liver Institute, Egypt:

Publications:
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Responsible Party: Mostafa M. Sira, Associate Professor of Pediatric Hepatology, National Liver Institute, Egypt
ClinicalTrials.gov Identifier: NCT02375867     History of Changes
Other Study ID Numbers: NLI-FHF-S-PED
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Hepatitis A
Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents