Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Diagnosis of primary sclerosing cholangitis (PSC) established by all of the following criteria:
- Alkaline phosphatase >1.5x upper limit of normal for at least 6 months prior to study enrollment
- Cholangiography demonstrating intrahepatic and/or extrahepatic biliary dilation, beading, and/or strictures consistent with PSC
- Liver histology (if available for review) consistent with or diagnostic of PSC
- Women of child-bearing potential willing to use birth control for the duration of the study.
- Treatment with any investigational agents within three months prior to or during the study
- Treatment with systemic antibiotics, azulfidine, systemic corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, or vitamin E within three months prior to or during the study.
- Concomitant treatment with NSAIDS, antiplatelet agents, antihyperlipidemics, and anticoagulant warfarin.
- Anticipated need for liver transplant within one year as determined by Mayo PSC risk score (<80% one-year survival without transplant)
- Active drug or alcohol use
- Findings suggestive of liver disease of an alternative or concomitant etiology, such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis (e.g., post-liver transplantation biliary stricture)
- Pregnancy or lactation
- Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.