Belimumab in Autoimmune Hepatitis
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
| Condition(s) | Autoimmune Hepatitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 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 open label clinical trial. Group A: * ALT \> 1.5 x ULN in the absence of clinical evidence or concern for alternative etiology, and assessed by the investigator as related to active AIH using standard of care evaluation. * Ongoing therapy with corticosteroids, and/or non-biologic immunosuppressants (AZA, MMF, MP) at a stable dosage for 4 weeks prior to screening Group B: * Patients with normal ALT and normal IgG concentration * Ongoing therapy with single agent immunosuppression or immunosuppression with low dose Prednisone (10mg or less or budesonide |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | University Health Network, Toronto |
| Locations | Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Toronto, Ontario, Canada |
| Start date | 2024-12-11 |
| NCT ID | NCT06381453 |
| Official listing | https://clinicaltrials.gov/study/NCT06381453 |