Study Results
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Basic Information
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COMPLETED
109 participants
OBSERVATIONAL
2019-12-17
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Pediatric AIH
Patients diagnosed with hepatitis type 1 and type 2 formulated between the ages of 0 and 18.
pediatric AIH
pediatric patients with clinical, laboratory (transaminase and IgG increase), instrumental (ultrasound, liver biopsy) characteristics
Interventions
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pediatric AIH
pediatric patients with clinical, laboratory (transaminase and IgG increase), instrumental (ultrasound, liver biopsy) characteristics
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of other causes of liver disease
* Presence of overlap syndrome (hepatito-cholangitis)
18 Years
ALL
No
Sponsors
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University Hospital of Ferrara
OTHER
Responsible Party
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Giuseppe Maggiore
Full Professor
Locations
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University Hospital of Ferrara
Cona, Ferrara, Italy
Countries
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References
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Jimenez-Rivera C, Ling SC, Ahmed N, Yap J, Aglipay M, Barrowman N, Graitson S, Critch J, Rashid M, Ng VL, Roberts EA, Brill H, Dowhaniuk JK, Bruce G, Bax K, Deneau M, Guttman OR, Schreiber RA, Martin S, Alvarez F. Incidence and Characteristics of Autoimmune Hepatitis. Pediatrics. 2015 Nov;136(5):e1237-48. doi: 10.1542/peds.2015-0578. Epub 2015 Oct 19.
Verma S, Torbenson M, Thuluvath PJ. The impact of ethnicity on the natural history of autoimmune hepatitis. Hepatology. 2007 Dec;46(6):1828-35. doi: 10.1002/hep.21884.
Nastasio S, Sciveres M, Matarazzo L, Maggiore G. Old and New Treatments for Pediatric Autoimmune Hepatitis. Curr Pediatr Rev. 2018;14(3):187-195. doi: 10.2174/1573396314666180516130314.
Maggiore G, Porta G, Bernard O, Hadchouel M, Alvarez F, Homberg JC, Alagille D. Autoimmune hepatitis with initial presentation as acute hepatic failure in young children. J Pediatr. 1990 Feb;116(2):280-2. doi: 10.1016/s0022-3476(05)82892-6. No abstract available.
Alvarez F, Berg PA, Bianchi FB, Bianchi L, Burroughs AK, Cancado EL, Chapman RW, Cooksley WG, Czaja AJ, Desmet VJ, Donaldson PT, Eddleston AL, Fainboim L, Heathcote J, Homberg JC, Hoofnagle JH, Kakumu S, Krawitt EL, Mackay IR, MacSween RN, Maddrey WC, Manns MP, McFarlane IG, Meyer zum Buschenfelde KH, Zeniya M, et al. International Autoimmune Hepatitis Group Report: review of criteria for diagnosis of autoimmune hepatitis. J Hepatol. 1999 Nov;31(5):929-38. doi: 10.1016/s0168-8278(99)80297-9. No abstract available.
Mieli-Vergani G, Vergani D, Baumann U, Czubkowski P, Debray D, Dezsofi A, Fischler B, Gupte G, Hierro L, Indolfi G, Jahnel J, Smets F, Verkade HJ, Hadzic N. Diagnosis and Management of Pediatric Autoimmune Liver Disease: ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. 2018 Feb;66(2):345-360. doi: 10.1097/MPG.0000000000001801.
Other Identifiers
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637/2019/Oss/AOUFe
Identifier Type: -
Identifier Source: org_study_id
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