Belimumab in Autoimmune Hepatitis

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Belimumab to treat autoimmune hepatitis (AIH), a chronic liver disease that happens when the immune system mistakenly attacks the liver. The trial aims to find out if adding Belimumab to standard treatments can help patients better control their disease while reducing the need for other medications. Researchers will look at how effective and safe Belimumab is for patients who are experiencing active disease or those who are in remission but still receiving treatment.

To participate in this trial, patients need to have a confirmed diagnosis of autoimmune hepatitis for at least six months. Those with ongoing active disease will be part of one group, while those in remission will be in another. Participants will receive Belimumab through a weekly injection for about 72 weeks. During this time, doctors will monitor their liver health, overall quality of life, and any side effects from the treatment. This study is currently recruiting patients and aims to involve 48 individuals from across Canada. If you or someone you know has AIH and is interested in this trial, it could be a valuable opportunity to explore a new treatment option.

Gender

ALL

Eligibility 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 \> 2 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 \>10 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