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Autoimmune Hepatitis in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04247490
Recruitment Status : Completed
First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Giuseppe Maggiore, University Hospital of Ferrara

Brief Summary:
Autoimmune hepatitis (AIH) is an immune-mediated and inflammatory liver disorder. It is currently divided into types 1 and 2, differentiated and defined by the presence of specific autoantibodies. The objectives are to describe the prevalence and incidence of type 1 and 2 autoimmune hepatitis and to analyze the clinics, biochemical and histopathological profiles at diagnosis and follow-up, initial therapy, response to therapy and long-term follow-up in three Italian centers of patients with type 1 and type 2 AIH.

Condition or disease Intervention/treatment
Autoimmune Hepatitis Diagnostic Test: pediatric AIH

Detailed Description:

Background: Autoimmune hepatitis (AIH) is an immune-mediated and inflammatory liver disorder with typical onset in pediatric age. It is currently divided into types 1 and 2, differentiated and defined by the presence of specific autoantibodies. AIH type 1 (AIH-1) is characterised by smooth muscle and/or antinuclear autoantibodies (SMA/ANA) while anti-liver kidney microsomal (anti-LKM) or liver cytosol type 1 (anti-LC1) identified AIH type 2 (AIH-2). The conventional treatment is based on corticosteroids and azathioprine as first line therapy. The optimal duration is not clear definied, however it should be extended for at least five years due to the frequent relapses.

Aims of the study: The primary objective is to describe the prevalence and incidence of type 1 and 2 autoimmune hepatitis on a selected italian pediatric population. Secondary objectives are to analyze the clinical, biochemical and histopathological profiles at diagnosis and follow-up, type of treatment received, response to therapy and long-term follow-up.

Methods: The investigators conducted a retrospective and prospective cohort study on patients aged ≤ 18 years who the diagnosis of AIH 1 and 2 between 01/01/1989 and 31/12/2019 and were followed in three Italian pediatric centers.

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Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentric Study on the Long-term Follow-up of Autoimmune Hepatitis in the Pediatric Patients
Actual Study Start Date : December 17, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pediatric AIH
Patients diagnosed with hepatitis type 1 and type 2 formulated between the ages of 0 and 18.
Diagnostic Test: pediatric AIH
pediatric patients with clinical, laboratory (transaminase and IgG increase), instrumental (ultrasound, liver biopsy) characteristics




Primary Outcome Measures :
  1. Prevalence and incidence [ Time Frame: from 01/01/1989 to 31/12/2019 ]
    The primary objective was to calculate the proportion of AIH type 1 and 2 patients present in the Italian pediatric population at a given time (prevalence) and the proportion of new AIH type 1 and 2 patients in the Italian pediatric population (0-18 years) in a given period of time (incidence).


Secondary Outcome Measures :
  1. Characteristics of AIH in pediatric patients [ Time Frame: from 01/01/1989 to 31/12/2019 ]
    Describe the baseline characteristics (age of onset, clinical-laboratory, radiological and histological characteristics), the response to therapy (medical and / or the possible use of liver transplantation) and the follow-up of patients with autoimmune hepatitis type 1 and 2.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is represented by all the patients who presented the onset of Autoimmune hepatitis type 1 and type 2 from 01/01/1989 to 31/12/2019 and were followed at the Pediatric Hepatology Centers of Ferrara (Hospital Saint Anna of Cona), Naples (Federico II University Hospital) and Palermo (Mediterranean Institute for Transplants and Highly Specialized Therapies).
Criteria

Inclusion Criteria:

  • Age ≤ 18 years at the time of diagnosis
  • Diagnosis of autoimmune hepatitis type 1 or 2 according to the Mieli-Vergani score: a pre-treatment score> 15 or post-treatment> 17 indicates a definite diagnosis of Autoimmune Hepatitis; a pre-treatment score between 10 and 15 or post-treatment between 12 and 17 indicates a probable diagnosis.

Exclusion Criteria:

  • Age> 18 years at the time of diagnosis
  • Presence of other causes of liver disease
  • Presence of overlap syndrome (hepatito-cholangitis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247490


Locations
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Italy
University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
Sponsors and Collaborators
University Hospital of Ferrara
Publications of Results:
Other Publications:
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Responsible Party: Giuseppe Maggiore, Full Professor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT04247490    
Other Study ID Numbers: 637/2019/Oss/AOUFe
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Maggiore, University Hospital of Ferrara:
Autoimmune hepatitis
incidence
prevalence
immunosuppressive treatmen
liver transplantation
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases