Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381453
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-29
Brief Title:
Belimumab in Autoimmune Hepatitis
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Belimumab in the Management of Autoimmune Hepatitis A Multi-centre Open-label Trial of add-on Belimumab Therapy to Standard of Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BELief
Brief 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 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 autoimmune hepatitis the investigator will now formally study the effect of adding Belimumab to existing standard of care with the goal being to evaluate treatment efficacy the ability to reduce the burden of existing therapies whilst still controlling AIH disease and to describe the tolerability safety of Belimumab in people with AIH Study Design Open label multi-centre Canadian clinical trial Patient population Patients with autoimmune hepatitis excluding patients with decompensated liver disease who either have active disease despite standard of care Group A or who are maintained with disease remission using standard of care therapy Group B 48 patients will be recruited Intervention Weekly sub-cutaneous Belimumab Duration 72 weeks with interim analysis after 24 patients have been treated for 24 weeks target recruitment 48 patients Evaluation Safety Serum liver tests quality of life exploratory immunologic biomarkers optional liver biopsy or fine needle liver aspirate Primary end-point Group A 50 or more of subjects have an ALT2x ULN corticosteroids at a dose of 5mg of Prednisone or equivalent Group B 50 or more of subjects able to maintain remission normal ALT normal IgG on monotherapy with Belimumab Conclusion Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None