Clinical trial NCT03569826: Canadian Network for Autoimmune Liver Disease
Official title: Canadian Network for Autoimmune Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Bilary Cirrhosis (PBC)
Autoimmune Hepatitis
Overlap Syndrome
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis across Canada.

Brief summary: 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: Inclusion Criteria:

* Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Liver transplant-free survival over time
timeFrame: Up to 6 years or time of death/liver transplant
Secondary outcomes:
measure: Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)
timeFrame: Through study completion, an average of 6 months
measure: Short Form 36 (SF-36)
timeFrame: Through study completion, an average of 6 months
measure: PBC-40
timeFrame: Through study completion, an average of 6 months
measure: 5D Pruritus Scale
timeFrame: Through study completion, an average of 6 months
measure: Itch Visual Analog Scale
timeFrame: Through study completion, an average of 6 months
measure: Itch Numeric Rating Scale
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre (HDH Site)
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: McMaster University Medical Centre
state: Quebec
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University Health Network, Toronto General Hospital
name: Bettina Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Andrew Mason, MD
role: PRINCIPAL_INVESTIGATOR
References: