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

John E. Eaton15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Sclerosing Cholangitis

Interventions

CurcuminDRUG

Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Serum Alkaline Phosphatase (SAP)

Number of subjects who experience a reduction of Serum Alkaline Phosphatase (SAP) to less than 1.5 x Upper Limit of Normal or a 40% reduction between baseline and week 12.

Time frame: baseline, 12 weeks

Secondary Outcomes

Change in Serum Aspartate Aminotransferase (AST)

AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 Unit/Liter (U/L)

Time frame: Baseline, 12 weeks

Change in Total Bilirubin

Bilirubin is a yellowish pigment found in bile, a fluid made by the liver. A small amount of older red blood cells are replaced by new blood cells every day. Bilirubin is left after these older blood cells are removed. The liver helps break down bilirubin so that it can be removed from the body in the stool. The normal range for total bilirubin is 0.3 to 1.9 milligrams/deciliter (mg/dL)

Time frame: Baseline, 12 weeks

Change in C-Reactive Protein (CRP)

C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 milligrams/Liter (mg/L)

Time frame: Baseline, 12 weeks

Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score

The Mayo Risk Score (R) = (0.0295 \* (age in years)) + (0.5373 \* natural logarithm(total bilirubin in mg/dL)) - (0.8389 \* (serum albumin in g/dL)) + (0.5380 \* natural logarithm(AST in IU/L) + (1.2426 \* (points for variceal bleeding)) where: AST = serum aspartate aminotransferase level, Points for variceal bleeding: 0 if none, 1 if present. Each unit increase in the Mayo Risk Score (R) is associated with a 2.5-fold increase in the risk of death. Most references to the score round the coefficients to 2 decimal places. The score shows very slight upward slope over time in stable patients, but during the terminal phase it shows an acceleration in progression.

Data from ClinicalTrials.gov

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