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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978339
Recruitment Status : Completed
First Posted : November 30, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
EuroPharma, Inc.
Information provided by (Responsible Party):
John E. Eaton, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE November 22, 2016
First Posted Date  ICMJE November 30, 2016
Results First Submitted Date  ICMJE December 13, 2019
Results First Posted Date  ICMJE January 18, 2020
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE June 9, 2017
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2020)
Change in Serum Alkaline Phosphatase (SAP) [ Time Frame: baseline, 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
  • Proportion of Subjects Who Experience a 40% Reduction in Serum Alkaline Phosphatase (ALP) [ Time Frame: 12 weeks ]
  • Proportion of Subjects Who Experience a Decrease in Serum ALP to Less than 1.5 times the Upper Level of Normal [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2020)
  • Change in Serum Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 12 weeks ]
    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)
  • Change in Total Bilirubin [ Time Frame: Baseline, 12 weeks ]
    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)
  • Change in C-Reactive Protein (CRP) [ Time Frame: Baseline, 12 weeks ]
    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)
  • Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score [ Time Frame: Baseline, 12 weeks ]
    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.
  • Change in Fatigue Severity [ Time Frame: Baseline, 12 weeks ]
    Fatigue will be measured by a Modified Fatigue Impact Scale (MFIS). This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items. Subjects rate on a 5-point scale with 0 = never to 4 = almost always. The total score for the MFIS is the sum of the scores for the 21 items ranging from score of 0-84. Higher numbers indicate greater fatigue.
  • Change in Pruritus [ Time Frame: Baseline, 12 weeks ]
    Pruritus will be measured by the 5-D itch Scale. The 5-D itch scale was developed as a brief but multidimensional questionnaire designed to be useful as an outcome measure in clinical trials." The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items of the first four domains were measured on a five-point Likert scale (1 = Not present/resolved/never, 5 = Unbearable/getting worse/always).The distribution domain included 16 potential locations of itch, including 15 body part items and one point of contact with clothing or bandages.The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
  • Mean Change in Serum Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 12 weeks ]
  • Mean Change in Total Bilirubin [ Time Frame: Baseline, 12 weeks ]
  • Mean Change in Albumin [ Time Frame: Baseline, 12 weeks ]
  • Mean Change in C-Reactive Protein [ Time Frame: Baseline, 12 weeks ]
  • Mean Change in Mayo PSC Risk Score [ Time Frame: Baseline, 12 weeks ]
    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.
  • Mean Change in Self-Reported Health Status [ Time Frame: Baseline, 12 weeks ]
    Health Status will be measured by a linear Visual Analog Scale (VAS) ranging from 0 (as bad as it can be) to 10 (as good as it can be).
  • Mean Change in Fatigue Severity [ Time Frame: Baseline, 12 weeks ]
    Fatigue will be measured by a linear Visual Analog Scale (VAS) ranging from 0 (as bad as it can be) to 10 (as good as it can be).
  • Mean Change in Pruritus [ Time Frame: Baseline, 12 weeks ]
    Pruritus will be measured by a linear Visual Analog Scale (VAS) ranging from 0 (as bad as it can be) to 10 (as good as it can be).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
Official Title  ICMJE An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE Drug: Curcumin
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.
Other Name: CuraMed® softgel
Study Arms  ICMJE Experimental: Curcumin
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.
Intervention: Drug: Curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 8, 2019
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02978339
Other Study ID Numbers  ICMJE 14-002660
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party John E. Eaton, Mayo Clinic
Study Sponsor  ICMJE John E. Eaton
Collaborators  ICMJE EuroPharma, Inc.
Investigators  ICMJE
Principal Investigator: Nicholas F LaRusso, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP