Steroids in Fulminant Hepatitis A in the Pediatric Age Group

Fulminant Hepatic Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375867
• Other study ID #: NLI-FHF-S-PED
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2018
• Source: National Liver Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fulminant Hepatic Failure
• Hepatic Insufficiency
• Hepatitis
• Hepatitis A
• Liver Failure
• Liver Failure, Acute

Intervention

Drug:
• prednisolone
Oral administration of 1 mg/Kg/day
• methylprednisolone
Intravenous injection of 0.8 mg/kg/day

Locations

Country	Name	City	State
Egypt	National Liver Institute	Menoufia

Sponsors (2)

Lead Sponsor	Collaborator
National Liver Institute, Egypt	Quesna Central Hospital, Ministry Of Health, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Bernal W, Auzinger G, Dhawan A, Wendon J. Acute liver failure. Lancet. 2010 Jul 17;376(9736):190-201. doi: 10.1016/S0140-6736(10)60274-7. Review. — View Citation

Cochran JB, Losek JD. Acute liver failure in children. Pediatr Emerg Care. 2007 Feb;23(2):129-35. Review. — View Citation

Fujiwara K, Kojima H, Yasui S, Okitsu K, Yonemitsu Y, Omata M, Yokosuka O. Hepatitis A viral load in relation to severity of the infection. J Med Virol. 2011 Feb;83(2):201-7. doi: 10.1002/jmv.21958. — View Citation

Fujiwara K, Yasui S, Yonemitsu Y, Fukai K, Arai M, Imazeki F, Suzuki A, Suzuki H, Sadahiro T, Oda S, Yokosuka O. Efficacy of combination therapy of antiviral and immunosuppressive drugs for the treatment of severe acute exacerbation of chronic hepatitis B. J Gastroenterol. 2008;43(9):711-9. doi: 10.1007/s00535-008-2222-5. Epub 2008 Sep 20. — View Citation

Lahuna O, Rastegar M, Maiter D, Thissen JP, Lemaigre FP, Rousseau GG. Involvement of STAT5 (signal transducer and activator of transcription 5) and HNF-4 (hepatocyte nuclear factor 4) in the transcriptional control of the hnf6 gene by growth hormone. Mol Endocrinol. 2000 Feb;14(2):285-94. — View Citation

Seshadri R, Feldman BM, Ilowite N, Cawkwell G, Pachman LM. The role of aggressive corticosteroid therapy in patients with juvenile dermatomyositis: a propensity score analysis. Arthritis Rheum. 2008 Jul 15;59(7):989-95. doi: 10.1002/art.23829. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effect 1 Number of patients with anaphylaxis	Number of patients with anaphylaxis	2 months
Primary	Side effect 2 Number of patients with angioedema	Number of patients with angioedema	2 months
Primary	Side effect 3 Number of patients with cardiac arrest	Number of patients with cardiac arrest	2 months
Primary	Side effect 4 Number of patients with arrhythmias	Number of patients with arrhythmias	2 months
Primary	Side effect 5 Number of patients with circulatory collapse	Number of patients with circulatory collapse	2 months
Primary	Side effect 6 Number of patients with congestive heart failure	Number of patients with congestive heart failure	2 months
Primary	Side effect 7 Number of patients with pulmonary edema	Number of patients with pulmonary edema	2 months
Primary	Side effect 8 Number of patients with pancreatitis	Number of patients with pancreatitis	2 months
Secondary	Efficacy 1 Number of survivors	number of living patients	2 months
Secondary	Efficacy 2 Number of deaths	number of died patients	2 months
Secondary	Efficacy 3 serum prothrombin time	serum prothrombin time	72 hour
Secondary	Efficacy 3 grade of encephalopathy	grade of encephalopathy	72 hour
Secondary	Efficacy 4 duration of encephalopathy	duration of encephalopathy	2 months