Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage

NCT06078098 | Recruiting

• 1 other identifier: AIH Database
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Autoimmune Hepatitis (AIH) is chronic fibroinflammatory disease of the liver characterized by chronic, relapsing liver inflammation, and a risk for progression to liver failure and need for liver transplantation. No AIH-specific registry does exist in Italy, so that the actual epidemiology of the disease in the country is unknown. This is an observational, retrospective and prospective, multicenter study evaluating incidence, prevalence and disease course of AIH in subjects \> 1 years old in Italy.

Conditions

Autoimmune Hepatitis; Liver Disorder

Keywords

Autoimmune Hepatitis; National Database; Liver; Epidemiology

Outcome Measures

Primary Outcomes (14)

• Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 months

  Number of participants with Normalization of AST and ALT \<1 x upper limit of normal (ULN)) and normal IgG levels within 6 monthswithin 6 months

  Overall duration of the study (11 years)

• Number of participants with lack of biochemical response

  Number of participants with lack of biochemical response

  Overall duration of the study (11 years)

• Number of participants with <50% decrease of AST and ALT within 4 weeks after initiation of treatment

  Number of participants with \<50% decrease of AST and ALT within 4 weeks after initiation of treatment

  Overall duration of the study (11 years)

• Number of participants with Hepatitis Activity Index <4/18

  Number of participants with Hepatitis Activity Index \<4/18

  Overall duration of the study (11 years)

• Intolerance to treatment

  Any adverse event possibly related to treatment as assessed by the treating physician leading to potential discontinuation of the drug

  Overall duration of the study (11 years)

• Deep biochemical remissionof disease progression

  ALT less than 50% ULN and IgG\<12g/l

  Overall duration of the study (11 years)

• Relapse

  An increase in serum ALT levels above three times the ULN and/or an increase in serum IgG levels to more than 20 g/l

  Overall duration of the study (11 years)

• Number of participants with An increase in serum ALT levels above ULN on at least two occasions with an interval of 4 weeks

  Number of participants with An increase in serum ALT levels above ULN on at least two occasions with an interval of 4 weeks, with or without concomitant clinical symptoms and reinstitution of drug therapy after exclusion of other plausible causes for the elevated serum ALT

  Overall duration of the study (11 years)

• Number of participants with variceal bleeding requiring hospital admission

  Number of participants with variceal bleeding requiring hospital admission

  Overall duration of the study (11 years)

• Number of participants with first evidence of ascites requiring hospital admission

  Number of participants with first evidence of ascites requiring hospital admission

  Overall duration of the study (11 years)

• Number of participants with hepatic encephalopathy requiring hospital admission

  Number of participants with hepatic encephalopathy requiring hospital admission

  Overall duration of the study (11 years)

• Number of participants with serum bilirubin levels > 1.0 mg/dl on more than one consecutive sample

  Number of participants with serum bilirubin levels \> 1.0 mg/dl on more than one consecutive sample

  Overall duration of the study (11 years)

• Number of participants with platelet count < 150.000/mm3 on more than one consecutive sample

  Number of participants with platelet count \< 150.000/mm3 on more than one consecutive sample

  Overall duration of the study (11 years)

• Number of participants with albumin levels < 3.5 mg/dL on more than one consecutive sample

  Number of participants with albumin levels \< 3.5 mg/dL on more than one consecutive sample

  Overall duration of the study (11 years)

Secondary Outcomes (3)

• Liver stiffness

  Overall duration of the study (11 years)

• Number of participants achieving HAI score < 4 at follow-up biopsies

  Overall duration of the study (11 years)

• The time from the diagnosis of AIH to an event

  Overall duration of the study (11 years)

Study Arms (1)

AIH patients

AIH population in Italy aged at least 1 year

Other: Clinical Information

Interventions

Clinical Information OTHER

We will recruit AIH patients and collect important clinical information and laboratory investigation, together with biological samples.

Also known as: Laboratory information, Biological samples

AIH patients

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Italian AIH patients (diagnosis of AIH according to the most recent published guidelines EASL) aged at least 1 year

You may qualify if:

• All AIH patients living in Italy and aged at least 1 year can be included in the database.
• Willing and able to give informed consent prior to any study specific procedure being
• Diagnosis of AIH according to the most recent published guidelines (EASL)

You may not qualify if:

• Subject unwilling to participate at the study

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

Related Publications (7)

• Heneghan MA, Yeoman AD, Verma S, Smith AD, Longhi MS. Autoimmune hepatitis. Lancet. 2013 Oct 26;382(9902):1433-44. doi: 10.1016/S0140-6736(12)62163-1. Epub 2013 Jun 14.

  PMID: 23768844 BACKGROUND

• Sharma R, Verna EC, Soderling J, Roelstraete B, Hagstrom H, Ludvigsson JF. Increased Mortality Risk in Autoimmune Hepatitis: A Nationwide Population-Based Cohort Study With Histopathology. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2636-2647.e13. doi: 10.1016/j.cgh.2020.10.006. Epub 2020 Oct 14.

  PMID: 33065308 BACKGROUND

• Mack CL, Adams D, Assis DN, Kerkar N, Manns MP, Mayo MJ, Vierling JM, Alsawas M, Murad MH, Czaja AJ. Diagnosis and Management of Autoimmune Hepatitis in Adults and Children: 2019 Practice Guidance and Guidelines From the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722. doi: 10.1002/hep.31065. Epub 2020 May 12. No abstract available.

  PMID: 31863477 BACKGROUND

• Wong LL, Fisher HF, Stocken DD, Rice S, Khanna A, Heneghan MA, Oo YH, Mells G, Kendrick S, Dyson JK, Jones DEJ; UK-AIH Consortium. The Impact of Autoimmune Hepatitis and Its Treatment on Health Utility. Hepatology. 2018 Oct;68(4):1487-1497. doi: 10.1002/hep.30031.

  PMID: 29663477 BACKGROUND

• Pape S, Snijders RJALM, Gevers TJG, Chazouilleres O, Dalekos GN, Hirschfield GM, Lenzi M, Trauner M, Manns MP, Vierling JM, Montano-Loza AJ, Lohse AW, Schramm C, Drenth JPH, Heneghan MA; International Autoimmune Hepatitis Group (IAIHG) collaborators(double dagger). Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group. J Hepatol. 2022 Apr;76(4):841-849. doi: 10.1016/j.jhep.2021.12.041. Epub 2022 Jan 20.

  PMID: 35066089 BACKGROUND

• Heneghan MA, Shumbayawonda E, Dennis A, Ahmed RZ, Rahim MN, Ney M, Smith L, Kelly M, Banerjee R, Culver EL. Quantitative magnetic resonance imaging to aid clinical decision making in autoimmune hepatitis. EClinicalMedicine. 2022 Mar 21;46:101325. doi: 10.1016/j.eclinm.2022.101325. eCollection 2022 Apr.

  PMID: 35340625 BACKGROUND

• van Gerven NM, Verwer BJ, Witte BI, van Hoek B, Coenraad MJ, van Erpecum KJ, Beuers U, van Buuren HR, de Man RA, Drenth JP, den Ouden JW, Verdonk RC, Koek GH, Brouwer JT, Guichelaar MM, Mulder CJ, van Nieuwkerk KM, Bouma G; Dutch Autoimmune Hepatitis Working Group. Relapse is almost universal after withdrawal of immunosuppressive medication in patients with autoimmune hepatitis in remission. J Hepatol. 2013 Jan;58(1):141-7. doi: 10.1016/j.jhep.2012.09.009. Epub 2012 Sep 16.

  PMID: 22989569 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The collection of biological samples is facultative. Biological samples are collected at time of recruitment and on a yearly basis (for blood, urine and stools). The collection of liver tissue depends on the specific procedures (liver biopsy) which are performed based on clinical needs.

MeSH Terms

Conditions

Hepatitis, Autoimmune; Digestive System Diseases

Interventions

Clinical Laboratory Information Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Management Information Systems; Organization and Administration; Health Services Administration

Central Study Contacts

Pietro Invernizzi, MD

CONTACT

039 233 2187; pietro.invernizzi@unimib.it

Alessio Gerussi, MD

CONTACT

alessio.gerussi@unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 11 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: October 11, 2023
• Study Start: March 29, 2023
• Primary Completion (Estimated): March 29, 2034
• Study Completion (Estimated): March 29, 2034
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)