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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

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).

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Curcumin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis
Actual Study Start Date : June 9, 2017
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : January 8, 2019


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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.


  5. 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.

  6. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978339


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
Sponsors and Collaborators
John E. Eaton
EuroPharma, Inc.
Investigators
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Principal Investigator: Nicholas F LaRusso, M.D. Mayo Clinic
  Study Documents (Full-Text)

Documents provided by John E. Eaton, Mayo Clinic:
Additional Information:
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Responsible Party: John E. Eaton, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02978339    
Other Study ID Numbers: 14-002660
First Posted: November 30, 2016    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action