Adding Belimumab to Standard Treatment for Autoimmune Hepatitis A Canadian Multi-Center Open-Label Phase 2 Trial

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.

Belimumab in Autoimmune Hepatitis