Actively Recruiting
Belimumab in the Management of Autoimmune Hepatitis: A Multi-centre, Open-label Trial of add-on Belimumab Therapy to Standard of Care
Led by University Health Network, Toronto · Updated on 2026-04-24
48
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Autoimmune hepatitis (AIH) is a rare, lifelong liver disease that can worsen to severe liver damage if untreated. It involves immune system problems, including issues with B-cells, which play a role in the disease alongside T-cells. Current treatments focus on suppressing the immune system but can have side effects that affect quality of life. This trial studies the addition of Belimumab, a drug that targets B-cell activation, to standard care, aiming to assess its effects on disease control, treatment reduction, and safety in people with AIH. The study is an open-label, multi-center trial in Canada involving 48 patients with AIH, divided into two groups: those with active disease despite treatment and those in remission on standard therapy. Participants will receive a weekly 200 mg subcutaneous injection of Belimumab for 72 weeks. An interim analysis will be conducted after 24 patients have received treatment for 24 weeks. Optional liver biopsies or fine needle aspirates may be performed to explore immunologic markers. Participants will have regular assessments including liver blood tests, quality of life questionnaires, and monitoring of immunologic biomarkers at scheduled intervals throughout the 72 weeks. The primary goal is to evaluate if Belimumab can reduce disease activity and corticosteroid use or maintain remission safely. Safety and tolerability will be closely monitored, and the study aims to provide data to support further evaluation of Belimumab in AIH treatment.
CONDITIONS
Brief Title
Belimumab in Autoimmune Hepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent
- Established clinical diagnosis of autoimmune hepatitis for at least 6 months
- Participant and clinician consent to follow AIH study therapy guidance for the duration of the trial
- Group A: ALT greater than 1.5 times upper limit of normal (ULN) related to active AIH
- Group A: Stable dose of corticosteroids and/or non-biologic immunosuppressants for 4 weeks prior to screening
- Group B: Normal ALT and IgG levels
- Group B: On single agent immunosuppression or low dose Prednisone (10mg or less) or budesonide (6mg or less) with a second line agent
- Group B: Liver stiffness less than 16 kPa by Fibroscan
You will not qualify if you...
- Primary liver disease other than autoimmune hepatitis
- High probability of non-alcoholic fatty liver disease (NAFLD)
- ALT greater than 15 times ULN
- Positive for hepatitis B surface antigen, core antibody, or hepatitis C RNA
- Prior corticosteroid use above 15mg daily
- Positive pregnancy test or breastfeeding
- Advanced liver disease shown by total bilirubin above 3 times ULN, platelet count below 100 x10^9/L, or INR above 1.5
- Live vaccines within 30 days before or during the study
- Use of other biologic drugs including TNF inhibitors, abatacept, or tocilizumab within the washout period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 weeks
Participants receive weekly subcutaneous injections of Belimumab using an auto-injector as add-on therapy to their standard care for autoimmune hepatitis.
Weekly visits for up to 48 weeks
Trial Site Locations
Total: 5 locations
1
University of Calgary
Calgary, Alberta, Canada
Actively Recruiting
2
G.I Research Institute
Vancouver, British Columbia, Canada
Actively Recruiting
3
McMaster University
Hamilton, Ontario, Canada
Actively Recruiting
4
London Health Sciences Centre
London, Ontario, Canada
Actively Recruiting
5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
G
Gideon Hirschfield
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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