About this trial

CaNAL is a longitudinal observational cohort study of patients diagnosed with Primary Biliary Cholangitis (PBC), Autoimmune Hepatitis (AIH), or overlap syndrome. This study creates a nationwide registry and network focusing on high quality long-term follow-up of individual patient data from major Canadian centers.

Primary Biliary Cholangitis (PBC) and Autoimmune Hepatitis (AIH) are rare and slowly progressive liver diseases associated with development of cirrhosis, liver cancer (HCC) and liver failure requiring liver transplantation or leading to premature death. The rarity and slowly progressive nature of these autoimmune liver diseases make them difficult to study and only a large scale approach combining patient data from multiple centers across Canada will allow new insights. The primary aim of the Canadian Network for Autoimmune Liver Disease is to build a Canadian registry of patients with PBC, AIH, and overlap syndrome. We capture patient characteristics, laboratory assessments and natural history, patient-reported outcomes including quality of life measures and environmental exposures, response to treatment, and pre- and post-transplant outcomes. We will then identify risk factors associated with critical outcomes for the patient, including response to treatment, progression to transplant, risk of liver cancer, and recurrent disease after transplant. We can identify biomarkers (biochemical indicators of progression of disease) to help diagnose autoimmune liver disease at its earliest stages, ensuring timely treatment and preventing disease progression. CaNAL will provide a better understanding of autoimmune liver diseases, biomarkers predictive of disease progression or non-response to therapy as well as better knowledge of the etiology and pathogenesis. CaNAL will also help to serve as a platform for conducting clinical trials or targeted lab-studies to answer important questions that are unlikely to be evaluated by the pharmaceutical industry.

Eligibility criteria

Qualifiers

Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Disqualifiers

Less than 18 years of age

Trial design

Treatments tested in this trial

  • Observational; no intervention

Treatment groups

2,500 Participants
are divided into 1 treatment group

Locations

15
Alberta
Foothills Medical CentreT2N 2T9, Calgary Canada
University of Alberta HospitalT6G 2B7, Edmonton Canada
British Columbia
St. Paul's HospitalV6Z 1Y6, Vancouver Canada
Vancouver General HospitalV5Z 1M9, Vancouver Canada

Sponsors and collaborators

University Health Network, Toronto

Lead sponsor