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New treatment option for Autoimmune Hepatitis
Official title Belimumab in Autoimmune Hepatitis
ClinicalTrials.gov ID: NCT06381453
What this study is testing
What is Belimumab Auto-Injector [Benlysta]?
Belimumab Auto-Injector [Benlysta] is an investigational medicine, given as an once-weekly, being studied as a potential treatment for autoimmune hepatitis.
Also referred to as Benlysta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Ongoing therapy with corticosteroids, and/or non-biologic immunosuppressants (AZA, MMF, MP) at a stable dosage for 4 weeks prior to screening Group B:
You likely can't join if
- 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
See the full eligibility 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.
- 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:
- Total Bilirubin \>3 x ULN.
- Platelet count \<100 x109/L.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.