Autoimmune Hepatitis in Pediatric Patients

NCT04247490 | Completed

• 1 other identifier: 637/2019/Oss/AOUFe
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hepatitis

Keywords

Autoimmune hepatitis; incidence; prevalence; immunosuppressive treatmen; liver transplantation

Outcome Measures

Primary Outcomes (1)

• Prevalence and incidence

  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).

  from 01/01/1989 to 31/12/2019

Secondary Outcomes (1)

• Characteristics of AIH in pediatric patients

  from 01/01/1989 to 31/12/2019

Study Arms (1)

Pediatric AIH

Patients diagnosed with hepatitis type 1 and type 2 formulated between the ages of 0 and 18.

Diagnostic Test: pediatric AIH

Interventions

pediatric AIH DIAGNOSTIC_TEST

pediatric patients with clinical, laboratory (transaminase and IgG increase), instrumental (ultrasound, liver biopsy) characteristics

Pediatric AIH

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related Publications (6)

• 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.

  PMID: 26482664 BACKGROUND

• 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.

  PMID: 17705297 RESULT

• 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.

  PMID: 29766815 RESULT

• 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.

  PMID: 2299503 RESULT

• 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.

  PMID: 10580593 RESULT

• 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.

  PMID: 29356770 RESULT

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 30, 2020
• Study Start: December 17, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)