Using Belimumab to treat Autoimmune Hepatitis
Belimumab in the Management of Autoimmune Hepatitis: A Multi-centre, Open-label Trial of add-on Belimumab Therapy to Standard of Care
This study is testing if Belimumab can help people with autoimmune hepatitis feel better and improve their liver function when other treatments haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | tocilizumab, Prednisone, Rituximab, Belimumab |
| Locations | 5 sites (Calgary, Alberta and 4 other locations) |
| Trial ID | NCT06381453 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Belimumab, an auto-injector medication, in treating patients with autoimmune hepatitis (AIH). The study aims to assess the impact of this targeted therapy on liver function and overall patient quality of life, particularly for those who have not responded well to existing treatments. Participants will be divided into two groups based on their liver enzyme levels and current immunosuppressive therapy. The trial will follow an open-label design, allowing for real-time assessment of treatment effects.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed diagnosis of autoimmune hepatitis who have been on stable immunosuppressive therapy for at least four weeks.
Not a fit: Patients with primary liver diseases other than autoimmune hepatitis or those with high probability of alternative etiologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and targeted therapy option for patients suffering from autoimmune hepatitis.
How similar studies have performed: Other studies have shown promise in targeting B-cells for autoimmune conditions, suggesting potential for success with this approach in autoimmune hepatitis.
Eligibility criteria
Show full inclusion / exclusion criteria
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 6mg or less)) alongside a second line agent (azathioprine, MMF, MP) * Fibroscan showing liver stiffness of \< 16kPa. Exclusion Criteria: * Primary liver disease other than AIH * High probability of NAFLD as assessed by the investigator. * ALT \>15 x ULN * Patients positive for HBsAg or HBcAb and/or Hepatitis C RNA * Prior use if corticosteroid \>15mg daily * A positive pregnancy test and/or breast feeding * The presence of advanced liver disease as defined by any of: 1. Total Bilirubin \>3 x ULN. 2. Platelet count \<100 x109/L. 3. INR \>1.5 * Live vaccines within 30 days prior to screening or at any time during the study * The use of other biologics including TNF inhibitors, abatacept, or tocilizumab within the washout period
Where this trial is running
Calgary, Alberta and 4 other locations
- 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)
Study contacts
- Principal investigator: Gideon Hirschfield, MB BChir, PhD — University Health Network, Toronto
- Study coordinator: Gideon Hirschfield
- Email: BELief@uhn.ca
- Phone: 416 340 4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.