Canadian Network for Autoimmune Liver Disease

Autoimmune Hepatitis Clinical Trial

— CaNAL  

Official title:

Canadian Network for Autoimmune Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03569826
• Other study ID #: CAPCR ID: 18-5951
• Status: Recruiting
• Start date: February 7, 2018
• Est. completion date: December 2028

Study information

• Verified date: June 2021
• Source: University Health Network, Toronto
• Contact: Surain Roberts, AB
• Phone: 613 291 5039
• Email: surain.roberts[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Exclusion Criteria:

• Less than 18 years of age

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis, Autoimmune
• Liver Diseases
• Overlap Syndrome
• Primary Bilary Cirrhosis (PBC)
• Undifferentiated Connective Tissue Diseases

Intervention

Other:
• Observational; no intervention
Observational; no intervention

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	Kingston Health Sciences Centre (HDH Site)	Kingston	Ontario
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	McMaster University Medical Centre	Montreal	Quebec
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Université de Sherbrooke	Sherbrooke	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver transplant-free survival over time	Time-to-event	Up to 6 years or time of death/liver transplant
Secondary	Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)	Investigate trends of different biochemical values over time	Through study completion, an average of 6 months
Secondary	Short Form 36 (SF-36)	Health-Related Quality of Life	Through study completion, an average of 6 months
Secondary	PBC-40	Health-Related Quality of Life, specific to Primary Biliary Cholangitis	Through study completion, an average of 6 months
Secondary	5D Pruritus Scale	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	Through study completion, an average of 6 months
Secondary	Itch Visual Analog Scale	Itch-Related Quality of Life; Continuous unitless itch scale from no itch to worst itch imaginable	Through study completion, an average of 6 months
Secondary	Itch Numeric Rating Scale	Itch-Related Quality of Life; Categorical integer scale from 0 (no itch) to 10 (worst itch imaginable)	Through study completion, an average of 6 months