NCT06020976

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 27, 2023

Last Update Submit

August 27, 2023

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (2)

  • liver biobsy

    to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation

    1 year

  • 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

Interventions

liver biobsyDIAGNOSTIC_TEST

all pationt will be subjected yo liver biobsy to confirm diagnosis

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

* Age: under 18 years old. * Both sex. * children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis-

You may qualify if:

  • Age: under 18 years old.
  • Both sex.
  • children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 19561543BACKGROUND

  • 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.

    PMID: 25067998BACKGROUND

  • 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.

    PMID: 20513004BACKGROUND

  • 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.

    PMID: 29644994BACKGROUND

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

fathy M abdelhahakam, resident

CONTACT

01270255316fathymohamed@med.sohag.edu.eg

Ashraf M Radwan, assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-pediatric department-sohag hospital university

Study Record Dates

First Submitted

August 27, 2023

First Posted

September 1, 2023

Study Start

September 10, 2023

Primary Completion

September 10, 2024

Study Completion

September 10, 2024

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

EG(1)