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Steroids in Fulminant Hepatitis A in the Pediatric Age Group

Primary Purpose

Fulminant Hepatic Failure

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

prednisolone

methylprednisolone

About this trial

This is an interventional treatment trial for Fulminant Hepatic Failure

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

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).

Sites / Locations

National Liver Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

prednisolone

methylprednisolone

Non-intervention

Arm Description

This group includes patients with FHF without encephalopathy

This group includes patients with FHF with encephalopathy

FHF patients without any of the proposed intervention as controls

Outcomes

Primary Outcome Measures

Side effect 1 Number of patients with anaphylaxis

Number of patients with anaphylaxis

Side effect 2 Number of patients with angioedema

Number of patients with angioedema

Side effect 3 Number of patients with cardiac arrest

Number of patients with cardiac arrest

Side effect 4 Number of patients with arrhythmias

Number of patients with arrhythmias

Side effect 5 Number of patients with circulatory collapse

Number of patients with circulatory collapse

Side effect 6 Number of patients with congestive heart failure

Number of patients with congestive heart failure

Side effect 7 Number of patients with pulmonary edema

Number of patients with pulmonary edema

Side effect 8 Number of patients with pancreatitis

Number of patients with pancreatitis

Secondary Outcome Measures

Efficacy 1 Number of survivors

number of living patients

Efficacy 2 Number of deaths

number of died patients

Efficacy 3 serum prothrombin time

serum prothrombin time

Efficacy 3 grade of encephalopathy

grade of encephalopathy

Efficacy 4 duration of encephalopathy

duration of encephalopathy

Full Information

NCT ID

NCT02375867

First Posted

February 14, 2015

Last Updated

December 14, 2018

Sponsor

National Liver Institute, Egypt

Collaborators

Quesna Central Hospital, Ministry Of Health, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT02375867

Brief Title

Steroids in Fulminant Hepatitis A in the Pediatric Age Group

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Liver Institute, Egypt

Collaborators

Quesna Central Hospital, Ministry Of Health, Egypt

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fulminant Hepatic Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prednisolone

Arm Type

Active Comparator

Arm Description

This group includes patients with FHF without encephalopathy

Arm Title

methylprednisolone

Arm Type

Active Comparator

Arm Description

This group includes patients with FHF with encephalopathy

Arm Title

Non-intervention

Arm Type

No Intervention

Arm Description

FHF patients without any of the proposed intervention as controls

Intervention Type

Drug

Intervention Name(s)

prednisolone

Other Intervention Name(s)

Hostacortin-H

Intervention Description

Oral administration of 1 mg/Kg/day

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Other Intervention Name(s)

Solumedrol

Intervention Description

Intravenous injection of 0.8 mg/kg/day

Primary Outcome Measure Information:

Title

Side effect 1 Number of patients with anaphylaxis

Description

Number of patients with anaphylaxis

Time Frame

2 months

Title

Side effect 2 Number of patients with angioedema

Description

Number of patients with angioedema

Time Frame

2 months

Title

Side effect 3 Number of patients with cardiac arrest

Description

Number of patients with cardiac arrest

Time Frame

2 months

Title

Side effect 4 Number of patients with arrhythmias

Description

Number of patients with arrhythmias

Time Frame

2 months

Title

Side effect 5 Number of patients with circulatory collapse

Description

Number of patients with circulatory collapse

Time Frame

2 months

Title

Side effect 6 Number of patients with congestive heart failure

Description

Number of patients with congestive heart failure

Time Frame

2 months

Title

Side effect 7 Number of patients with pulmonary edema

Description

Number of patients with pulmonary edema

Time Frame

2 months

Title

Side effect 8 Number of patients with pancreatitis

Description

Number of patients with pancreatitis

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Efficacy 1 Number of survivors

Description

number of living patients

Time Frame

2 months

Title

Efficacy 2 Number of deaths

Description

number of died patients

Time Frame

2 months

Title

Efficacy 3 serum prothrombin time

Description

serum prothrombin time

Time Frame

72 hour

Title

Efficacy 3 grade of encephalopathy

Description

grade of encephalopathy

Time Frame

72 hour

Title

Efficacy 4 duration of encephalopathy

Description

duration of encephalopathy

Time Frame

2 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanaa El-Araby, M.D.

Organizational Affiliation

Pediatric Hepatology Department, National Liver Institute, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mostafa M Sira, M.D.

Organizational Affiliation

Pediatric Hepatology Department, National Liver Institute, Egypt

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Haydi M Zakaria, M.Sc.

Organizational Affiliation

Quesna Central Hospital, Ministry Of Health, Egypt

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tahany A Salem, M.Sc.

Organizational Affiliation

Pediatric Hepatology Department, National Liver Institute, Egypt

Official's Role

Study Chair

Facility Information:

Facility Name

National Liver Institute

City

Menoufia

ZIP/Postal Code

32511

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

17351416

Citation

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

Results Reference

background

PubMed Identifier

20638564

Citation

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.

Results Reference

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PubMed Identifier

21181913

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.

Results Reference

background

PubMed Identifier

18807133

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.

Results Reference

background

PubMed Identifier

10674400

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. doi: 10.1210/mend.14.2.0423.

Results Reference

background

PubMed Identifier

18576304

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.

Results Reference

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Steroids in Fulminant Hepatitis A in the Pediatric Age Group

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