Immunogenetic and therapeutic aspects of Autoimmune Hepatitis

Immunogenetic and therapeutic aspects of Autoimmune Hepatitis - Autoimmune hepatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44835

Enrollment

2000

Registered

2008-06-20

Start date

2009-01-09

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflamed liver

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men and women * 18 years of age Definite or probable AIH according to AASLD/IAIHG guidelines16 (appendix 1), including overlap syndromes Informed consent

Exclusion criteria

Exclusion criteria: History of liver disease, other than AIH, PSC or PBC A psychiatric, addictive or any disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study

Design outcomes

Primary

Measure	Time frame
* Main study parameters/endpoints * The level and pattern of expression of candidate genes using appropriate techniques	—

Secondary

Measure	Time frame
* Secondary study parameters/endpoints * Determination of point prevalence (2008, 2009) * Annual incidence of AIH in the defined region, based on newly diagnosed cases in the period between 01-01-2000 and 01-07-2009, frequencies of AIH types in registered patients * Natural history of AIH with respect to estimated survival, orthotopic liver transplantation (OLT) and the occurrence of hepatocellular carcinoma (HCC), proportion of patients using medication, divided by sort, dosage duration of use and effect * Pharmacokinetic and pharmacodynamic features of azathioprine and its metabolites, Cmax, Tmax, T1/2, TPMT activity, clinical effects, effects on disease activity. The immunophenotype of the intrahepatic inflammation measured with immunohistochemical staining on biobank leftover material.	—

Measure

Time frame

* Secondary study parameters/endpoints * Determination of point prevalence (2008, 2009) * Annual incidence of AIH in the defined region, based on newly diagnosed cases in the period between 01-01-2000 and 01-07-2009, frequencies of AIH types in registered patients * Natural history of AIH with respect to estimated survival, orthotopic liver transplantation (OLT) and the occurrence of hepatocellular carcinoma (HCC), proportion of patients using medication, divided by sort, dosage duration of use and effect * Pharmacokinetic and pharmacodynamic features of azathioprine and it*s metabolites, Cmax, Tmax, T1/2, TPMT activity, clinical effects, effects on disease activity. * The immunophenotype of the intrahepatic inflammation measured with immunohistochemical staining on biobank leftover material.

—

Countries

Netherlands

Outcome results