跳至主要内容
临床试验/NCT03569826
NCT03569826招募中不适用

Canadian Network for Autoimmune Liver Disease

University Health Network, Toronto14 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2018年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,500
试验地点
14
主要终点
Liver transplant-free survival over time

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

排除标准

  • Less than 18 years of age

结局指标

主要结局

Liver transplant-free survival over time

时间窗: Up to 6 years or time of death/liver transplant

Time-to-event

次要结局

  • Short Form 36 (SF-36)(Through study completion, an average of 6 months)
  • PBC-40(Through study completion, an average of 6 months)
  • Itch Visual Analog Scale(Through study completion, an average of 6 months)
  • Itch Numeric Rating Scale(Through study completion, an average of 6 months)
  • Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)(Through study completion, an average of 6 months)
  • 5D Pruritus Scale(Through study completion, an average of 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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