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

• Status: Completed
• Trial end date: 2019-01-08
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John E. Eaton; Nicholas LaRusso
• Collaborator: EuroPharma, Inc.
• Treatments: Curcumin

Criteria

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.