A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)

An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis

The purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (PSC).

Inclusion 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.

Exclusion Criteria:

• 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.