Canadian Network for Autoimmune Liver Disease

Recruiting

• Conditions: Autoimmune Hepatitis; Overlap Syndrome; Primary Bilary Cirrhosis (PBC)
• Interventions: Other: Observational; no intervention

• Registration Number: NCT03569826
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-07
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-26
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-07
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Exclusion Criteria

• Less than 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Observational; no intervention	There is no intervention being administered. This registry only observes patients through their regular standard of care visits.

Primary Outcome Measures

Name	Time	Method
Liver transplant-free survival over time	Up to 6 years or time of death/liver transplant	Time-to-event

Secondary Outcome Measures

Name	Time	Method
Short Form 36 (SF-36)	Through study completion, an average of 6 months	Health-Related Quality of Life
PBC-40	Through study completion, an average of 6 months	Health-Related Quality of Life, specific to Primary Biliary Cholangitis
Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)	Through study completion, an average of 6 months	Investigate trends of different biochemical values over time
5D Pruritus Scale	Through study completion, an average of 6 months	Itch-Related Quality of Life through 5 dimensions: duration, degree, direction, disability, and distribution. Each dimension is scored from 1(lowest) to 5(highest) for a total score range of 5-25
Itch Visual Analog Scale	Through study completion, an average of 6 months	Itch-Related Quality of Life; Continuous unitless itch scale from no itch to worst itch imaginable
Itch Numeric Rating Scale	Through study completion, an average of 6 months	Itch-Related Quality of Life; Categorical integer scale from 0 (no itch) to 10 (worst itch imaginable)

Trial Locations

Locations (14)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada

McMaster University Medical Centre; 🇨🇦 Montreal, Quebec, Canada

Kingston Health Sciences Centre (HDH Site); 🇨🇦 Kingston, Ontario, Canada

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada