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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 months — Overall duration of the study (11 years)
  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
• Number of participants with lack of biochemical response — Overall duration of the study (11 years)
  Number of participants with lack of biochemical response
• 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 \<50% decrease of AST and ALT within 4 weeks after initiation of treatment
• Number of participants with Hepatitis Activity Index <4/18 — Overall duration of the study (11 years)
  Number of participants with Hepatitis Activity Index \<4/18
• Intolerance to treatment — Overall duration of the study (11 years)
  Any adverse event possibly related to treatment as assessed by the treating physician leading to potential discontinuation of the drug
• Deep biochemical remissionof disease progression — Overall duration of the study (11 years)
  ALT less than 50% ULN and IgG\<12g/l
• Relapse — Overall duration of the study (11 years)
  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
• Number of participants with An increase in serum ALT levels above ULN on at least two occasions with an interval of 4 weeks — 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, with or without concomitant clinical symptoms and reinstitution of drug therapy after exclusion of other plausible causes for the elevated serum ALT
• Number of participants with variceal bleeding requiring hospital admission — Overall duration of the study (11 years)
  Number of participants with variceal bleeding 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 first evidence of ascites requiring hospital admission
• Number of participants with hepatic encephalopathy requiring hospital admission — Overall duration of the study (11 years)
  Number of participants with hepatic encephalopathy requiring hospital admission
• 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 serum bilirubin levels \> 1.0 mg/dl 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 platelet count \< 150.000/mm3 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)
  Number of participants with albumin levels \< 3.5 mg/dL on more than one consecutive sample

Trial sites (1)

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