Using Belimumab to treat Autoimmune Hepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• The Ottawa General Hospital
  Ottawa, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.