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Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06020976
Enrollment
20
Registered
2023-09-01
Start date
2023-09-10
Completion date
2024-09-10
Last updated
2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DIAGNOSTIC_TESTliver biobsy

all pationt will be subjected yo liver biobsy to confirm diagnosis

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
liver biobsy1 yearto confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation
autoantibody1 yearAutoantibodies 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).

Countries

Egypt

Contacts

Primary Contactfathy M abdelhahakam, resident
fathymohamed@med.sohag.edu.eg01270255316
Backup ContactAshraf M Radwan, assistant professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026