Dissecting the Genetic Environment Contributions of Autoimmune Liver Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003369
Sponsor Protocol Number: 1403861741
About this study
The overall objective of this proposal is to conduct a systematic approach to dissect both genetic underpinnings and non-genetic factors in the development of adult autoimmune liver diseases including autoimmune hepatitis (AIH), overlap AIH with Primary Biliary Cirrhosis (AIH-PBC), overlap AIH with Primary Sclerosing Cholangitis (AIH-PSC), and drug-induced autoimmune-like hepatitis (DIAIH).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
AIH patients
- Male and female patients ages ≥ 7 years old.
- Diagnosis of probable AIH on the pretreatment score as defined by the International Autoimmune Hepatitis Group (IAIHG) revised criteria or
- Diagnosis of probable AIH confirmed by the IAIHG Simplified Criteria for the Diagnosis of Autoimmune Hepatitis score
AIH-PBC Patients
- Male and Female patients ages ≥ 7 years old.
- Diagnosis of AIH-PBC overlap syndrome defined by the association of PBC and probable AIH either simultaneously or consecutively.
AIH-PSC Patients
Diagnosis of AIH-PSC overlap syndrome defined by association of PSC and probable AIH
DIAIH Patients
- Male and Female patients ages ≥ 7 years old.
- Diagnosis of probable AIH on the pretreatment score as defined by the International Autoimmune Hepatitis Group (IAIHG) revised criteria or
- Diagnosis of probable AIH confirmed by the IAIHG Simplified Criteria for the Diagnosis of Autoimmune Hepatitis score
- Presence of a suspicion of drug etiology in triggering an AIH clinical picture.
Control Patients
- Male and Female patients ages ≥ 7 years old.
- No evidence, history or diagnosis of a chronic liver disease in medical history
Exclusion Criteria:
All AIH, overlap, DIAIH patients, and controls:
- Prisoners and institutionalized individuals
- Patients unable to provide consent
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available