Clinical Trial TitleThe PORTOLA Study: A Randomized, Phase 2a, Investigational Drug vs Placebo Study Evaluating the Safety and Efficacy of an Investigational Drug in Patients with Autoimmune Hepatitis (AIH)
National Clinical Trial Number:NCT05569759
Clinical Trial Protocol Description:
This is a study looking at how safe and how well a specific investigational drug works in patients with AIH who are not responding to standard of care treatment. This study is being conducted at the Rush University downtown campus so you must be willing to come to that location for research visits.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a clinical diagnosis of AIH and signs of active disease despite standard-of-care therapy.
- Are willing to use and taper glucocorticoid therapy.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of thyroiditis, celiac disease, or other autoimmune disorder known to be associated with transaminitis.
- Have taken rituximab, other B- or T-cell depleting agents, or alkylating agents within 6 months of Screening, unless B- or T-cells have been shown to return to normal values.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.