Condition: Autoimmune Hepatitis · Sponsor: University Health Network, Toronto
Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic \& environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoi…
This description comes directly from the study's public registry record.
Gideon Hirschfield · 416 340 4800 · BELief@uhn.ca
Always discuss trial participation with your own doctor first.
| University of Calgary | Calgary, Alberta, Canada | Recruiting |
| G.I Research Institute | Vancouver, British Columbia, Canada | Recruiting |
| McMaster University | Hamilton, Ontario, Canada | Recruiting |
| London Health Sciences Centre | London, Ontario, Canada | Recruiting |
| Toronto General Hospital | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06381453