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โ† Trials
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Belimumab in Autoimmune Hepatitis

RecruitingPhase 2Ages 18 Years - 80 YearsAllUniversity Health Network, Toronto
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In plain words

What the trial is, and whether it could suit you

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, ha

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Belimumab Auto-Injector [Benlysta]
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Where

6 sites
University of Calgary
Calgary, Canada
G.I Research Institute
Vancouver, Canada
McMaster University
Hamilton, Canada
London Health Sciences Centre
London, Canada
The Ottawa General Hospital
Ottawa, Canada
Toronto General Hospital
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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