Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Autoimmune Hepatitis Clinical Trial

Official title:

Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06020976
• Other study ID #: soh-Med-23-07-10MS
• Status: Not yet recruiting
• Start date: September 10, 2023
• Est. completion date: September 10, 2024

Study information

• Verified date: August 2023
• Source: Sohag University
• Contact: fathy M abdelhahakam, resident
• Phone: 01270255316
• Email: fathymohamed[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure.

Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria.

AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an acute severe fulminant disease.

It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes, vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis.

Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies.

Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where interface hepatitis is the hallmark of the disease.

Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the initial therapy either alone or in combination with azathioprine.

Liver transplantation is indicated in patients who develop fulminant hepatic failure that is unresponsive to corticosteroids and in patients who develop end-stage liver disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 10, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Age: under 18 years old.

• Both sex.

• children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis

Exclusion Criteria:

• Patient infected with hepatitis B or C.

• Patient had autoimmune hepatitis after liver transplantation.

• Patients not respond to steroids and immunosuppressive therapy. Other Causes of acute and chronich hepatitis like wilson disease and Metabolic liver Diseases

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

Diagnostic Test:
• liver biobsy
all pationt will be subjected yo liver biobsy to confirm diagnosis

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Maggiore G, Nastasio S, Sciveres M. Juvenile autoimmune hepatitis: Spectrum of the disease. World J Hepatol. 2014 Jul 27;6(7):464-76. doi: 10.4254/wjh.v6.i7.464. — View Citation

Manns MP, Czaja AJ, Gorham JD, Krawitt EL, Mieli-Vergani G, Vergani D, Vierling JM; American Association for the Study of Liver Diseases. Diagnosis and management of autoimmune hepatitis. Hepatology. 2010 Jun;51(6):2193-213. doi: 10.1002/hep.23584. No abstract available. — View Citation

Mieli-Vergani G, Heller S, Jara P, Vergani D, Chang MH, Fujisawa T, Gonzalez-Peralta RP, Kelly D, Mohan N, Shah U, Murray KF. Autoimmune hepatitis. J Pediatr Gastroenterol Nutr. 2009 Aug;49(2):158-64. doi: 10.1097/MPG.0b013e3181a1c265. — View Citation

Mieli-Vergani G, Vergani D, Czaja AJ, Manns MP, Krawitt EL, Vierling JM, Lohse AW, Montano-Loza AJ. Autoimmune hepatitis. Nat Rev Dis Primers. 2018 Apr 12;4:18017. doi: 10.1038/nrdp.2018.17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver biobsy	to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation	1 year
Primary	autoantibody	Autoantibodies will be considered positive and clinically significant when present at a dilution =1:20 for antinuclear antibody (ANA) and smooth muscle antibody (SMA) or =1:10 for liver kidney microsomal (anti-LKM-1).	1 year