Clinical trial NCT06020976: Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital
Official title: Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autoimmune Hepatitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Age: under 18 years old.
* Both sex.
* children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis-

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: liver biobsy
timeFrame: 1 year
measure: autoantibody
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
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.
citation: 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.
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.
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.