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NCT Number: NCT03569826

Canadian Network for Autoimmune Liver Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Exclusion criteria

  • Less than 18 years of age

Treatment and study plan

Observational; no intervention

Other

Observational; no intervention

Primary outcomes

  1. Liver transplant-free survival over time

    Time frame: Up to 6 years or time of death/liver transplant

    Time-to-event

Secondary outcomes

  1. Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)

    Time frame: Through study completion, an average of 6 months

    Investigate trends of different biochemical values over time

  2. Short Form 36 (SF-36)

    Time frame: Through study completion, an average of 6 months

    Health-Related Quality of Life

  3. PBC-40

    Time frame: Through study completion, an average of 6 months

    Health-Related Quality of Life, specific to Primary Biliary Cholangitis

  4. 5D Pruritus Scale

    Time frame: 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

  5. Itch Visual Analog Scale

    Time frame: Through study completion, an average of 6 months

    Itch-Related Quality of Life; Continuous unitless itch scale from no itch to worst itch imaginable

  6. Itch Numeric Rating Scale

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Kattleya Tirona, BA, CCRP

CONTACT

[email protected]

416 340 4800 ext. 6912

Surain Roberts, AB

CONTACT

[email protected]

613 291 5039

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: CaNAL

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2018
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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