Primary Bilary Cirrhosis (PBC)CaNALNCT03569826
Canadian Network for Autoimmune Liver Disease
An observational study of Primary Bilary Cirrhosis (PBC) and Autoimmune Hepatitis, run by University Health Network, Toronto at 15 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Bilary Cirrhosis (PBC), Autoimmune Hepatitis, Overlap Syndrome
- How many people
- 2,500 participants
- Where
- 15 sitesCanada
- Study dates
- 7 Feb 2018to Dec 2028
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis across Canada.
Who may be able to join
- Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis
Who cannot join
- Less than 18 years of age
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Canada15 sites, 13 recruiting
- Not yet recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Mark Swain, MD, 403-944-6514, swain@ucalgary.ca
Mark Swain, MD
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Andrew Mason, MD, 780-492-8176, am16@ualberta.ca
Ellina Lytvyak, lytvyak@ualberta.ca
- Active, not recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
- Not yet recruiting
McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1
Marco Puglia, MD
Marco Puglia, MD
- Active, not recruiting
Kingston Health Sciences Centre (HDH Site)
Kingston, Ontario, K7L 5G2
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
Karim Qumosani, MD, 519-663-3976, Karim.Qumosani@lhsc.on.ca
Karim Qumosani, MD
- Recruiting
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Catherine Vincent, MD, 514-890-8000 ext. 35705, catherine.vincent@umontreal.ca
Catherine Vincent, MD
- Not yet recruiting
McMaster University Medical Centre
Montreal, Quebec, H4A 3J1
Marc Deschenes
Hansi Peiris, 514-934-1934 ext. 76159, hansi.peiris@muhc.mcgill.ca
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Angela Cheung, MD, 613-737-8899 ext. 73224, angcheung@toh.ca
Miriam Muir, mmuir@toh.ca
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Lawrence Worobetz, MD, 306-966-7964, worobetz@sasktel.net
Lawrence Worobetz, MD
- Recruiting
Université de Sherbrooke
Sherbrooke, Quebec, J1G2E8
Dusanka Grbic, 819-346-1110, Dusanka.Grbic@usherbrooke.ca
Chantal Guillet, 819-346-1110 ext. 12821, chantal.guillet.ciussse-chus@ssss.gouv.qc.ca
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Bettina Hansen, PhD, 416-340-5157, bettina.hansen@utoronto.ca
Kattleya Tirona, kattleya.tirona@uhn.ca
- Not yet recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Eric M Yoshida, MD, 604-875-5371, eric.yoshida@vch.ca
Eric M Yoshida, MD
- Not yet recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Hin Hin Ko, MD, 604-688-6332
Hin Hin Ko, MD
- Not yet recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Nabiha Faisal, MD, 204-789-3650, Nabiha.Faisal@umanitoba.ca
Nabiha Faisal, MD
About this study
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.
- Being tested
- Observational; no intervention
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational; no interventionOther
Observational; no intervention
| Study group | Role | What they receive |
|---|---|---|
| Observational | There is no intervention being administered. This registry only observes patients through their regular standard of care visits. Receives: Other: Observational; no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver transplant-free survival over time
Time-to-event
Measured: Up to 6 years or time of death/liver transplant
Secondary outcomes (6)
Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)
Investigate trends of different biochemical values over time
Measured: Through study completion, an average of 6 months
Short Form 36 (SF-36)
Health-Related Quality of Life
Measured: Through study completion, an average of 6 months
PBC-40
Health-Related Quality of Life, specific to Primary Biliary Cholangitis
Measured: Through study completion, an average of 6 months
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
Measured: Through study completion, an average of 6 months
Itch Visual Analog Scale
Itch-Related Quality of Life; Continuous unitless itch scale from no itch to worst itch imaginable
Measured: Through study completion, an average of 6 months
Itch Numeric Rating Scale
Itch-Related Quality of Life; Categorical integer scale from 0 (no itch) to 10 (worst itch imaginable)
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start7 Feb 2018
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Bilary Cirrhosis (PBC)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Hansen, PhD, Principal investigator, University Health Network, Toronto General HospitalAndrew Mason, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569826
- Sponsor's protocol ID
- CAPCR ID: 18-5951
- Acronym
- CaNAL
- Status last verified
- Jun 2021
- First submitted
- 25 May 2018
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be anonymized. A standardized electronic case record (e-CRF) form will be used to capture the data. The e-CRF form has been designed in REDCap, a secure web based application supporting data capture for research studies. REDCap is designed to comply with HIPAA security regulations. The CaNAL REDCap database (REDCap project CaNAL) has been established at the University of Alberta under the jurisdiction of the Women and Children's Health Research Institute (WCHRI). Individual centres will have access only to their own data and patient identifiers will only be visible to the individual centres. The steering committee will have access to all anonymized data within the REDCap database, that is without any patient identifiers. Main centres in Toronto and Edmonton will have access to de-identified data. Results will be disseminated via publication in international literature and presentation at international liver conferences. Patient data will be anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Network for Autoimmune Liver Disease
- ClinicalTrials.gov ID
- NCT03569826
- Acronym / sponsor ID
- CaNAL / CAPCR ID: 18-5951
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Observational; no interventionThere is no intervention being administered. This registry only observes patients through their regular standard of care visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis across Canada.
Key inclusion criteria (1 listed)
- Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis
Key exclusion criteria (1 listed)
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational; no interventionObservational; no intervention | Other | Observational |
Primary outcome
Liver transplant-free survival over time
Time frame: Up to 6 years or time of death/liver transplant
Time-to-event
6 secondary outcomes
Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)
Time frame: Through study completion, an average of 6 months
Short Form 36 (SF-36)
Time frame: Through study completion, an average of 6 months
PBC-40
Time frame: Through study completion, an average of 6 months
5D Pruritus Scale
Time frame: Through study completion, an average of 6 months
Itch Visual Analog Scale
Time frame: Through study completion, an average of 6 months
Itch Numeric Rating Scale
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No. Patient data will be anonymized. A standardized electronic case record (e-CRF) form will be used to capture the data. The e-CRF form has been designed in REDCap, a secure web based application supporting data capture for research studies. REDCap is designed to comply with HIPAA security regulations. The CaNAL REDCap database (REDCap project CaNAL) has been established at the University of Alberta under the jurisdiction of the Women and Children's Health Research Institute (WCHRI). Individual centres will have access only to their own data and patient identifiers will only be visible to the individual centres. The steering committee will have access to all anonymized data within the REDCap database, that is without any patient identifiers. Main centres in Toronto and Edmonton will have access to de-identified data. Results will be disseminated via publication in international literature and presentation at international liver conferences. Patient data will be anonymous.
Related trials for Primary Bilary Cirrhosis (PBC)
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bettina Hansen, PhD principal investigator
University Health Network, Toronto General Hospital
Andrew Mason, MD principal investigator
University of Alberta
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Bilary Cirrhosis (PBC) and Autoimmune Hepatitis, run by University Health Network, Toronto at 15 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Surain Roberts, AB (613 291 5039, surain.roberts@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver transplant-free survival over time (time frame: Up to 6 years or time of death/liver transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.