Steroids in Fulminant Hepatitis A in the Pediatric Age Group

NCT02375867 | Completed Phase 4 DMC

• 1 other identifier: NLI-FHF-S-PED
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Fulminant Hepatic Failure

Outcome Measures

Primary Outcomes (8)

• Side effect 1 Number of patients with anaphylaxis

  Number of patients with anaphylaxis

  2 months

• Side effect 2 Number of patients with angioedema

  Number of patients with angioedema

  2 months

• Side effect 3 Number of patients with cardiac arrest

  Number of patients with cardiac arrest

  2 months

• Side effect 4 Number of patients with arrhythmias

  Number of patients with arrhythmias

  2 months

• Side effect 5 Number of patients with circulatory collapse

  Number of patients with circulatory collapse

  2 months

• Side effect 6 Number of patients with congestive heart failure

  Number of patients with congestive heart failure

  2 months

• Side effect 7 Number of patients with pulmonary edema

  Number of patients with pulmonary edema

  2 months

• Side effect 8 Number of patients with pancreatitis

  Number of patients with pancreatitis

  2 months

Secondary Outcomes (5)

• Efficacy 1 Number of survivors

  2 months

• Efficacy 2 Number of deaths

  2 months

• Efficacy 3 serum prothrombin time

  72 hour

• Efficacy 3 grade of encephalopathy

  72 hour

• Efficacy 4 duration of encephalopathy

  2 months

Study Arms (3)

prednisolone

ACTIVE COMPARATOR

This group includes patients with FHF without encephalopathy

Drug: prednisolone

methylprednisolone

ACTIVE COMPARATOR

This group includes patients with FHF with encephalopathy

Drug: methylprednisolone

Non-intervention

NO INTERVENTION

FHF patients without any of the proposed intervention as controls

Interventions

prednisolone DRUG

Oral administration of 1 mg/Kg/day

Also known as: Hostacortin-H

prednisolone

methylprednisolone DRUG

Intravenous injection of 0.8 mg/kg/day

Also known as: Solumedrol

methylprednisolone

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• National Liver Institute, Egypt: lead
• Quesna Central Hospital, Ministry Of Health, Egypt: collaborator

Study Sites (1)

National Liver Institute

Menoufia, Menoufia, 32511, Egypt

Location

Related Publications (6)

• Cochran JB, Losek JD. Acute liver failure in children. Pediatr Emerg Care. 2007 Feb;23(2):129-35. doi: 10.1097/PEC.0b013e3180308f4b.

  PMID: 17351416 BACKGROUND

• 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.

  PMID: 20638564 BACKGROUND

• 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.

  PMID: 21181913 BACKGROUND

• 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.

  PMID: 18807133 BACKGROUND

• 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. doi: 10.1210/mend.14.2.0423.

  PMID: 10674400 BACKGROUND

• 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.

  PMID: 18576304 BACKGROUND

MeSH Terms

Conditions

Liver Failure, Acute

Interventions

Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hanaa El-Araby, M.D.

  Pediatric Hepatology Department, National Liver Institute, Egypt

  PRINCIPAL INVESTIGATOR

• Mostafa M Sira, M.D.

  Pediatric Hepatology Department, National Liver Institute, Egypt

  STUDY DIRECTOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Hepatology

Study Record Dates

• First Submitted: February 14, 2015
• First Posted: March 3, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

EG (1)