ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 : Active, not recruiting
First Posted : November 30, 2016
Last Update Posted : November 7, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


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. Proportion of Subjects Who Experience a 40% Reduction in Serum Alkaline Phosphatase (ALP) [ Time Frame: 12 weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. Mean Change in Serum Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 12 weeks ]
  2. Mean Change in Total Bilirubin [ Time Frame: Baseline, 12 weeks ]
  3. Mean Change in Albumin [ Time Frame: Baseline, 12 weeks ]
  4. Mean Change in C-Reactive Protein [ Time Frame: Baseline, 12 weeks ]
  5. 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.


  6. 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).

  7. 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).

  8. 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).



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.


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

Responsible Party: John E. Eaton, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02978339     History of Changes
Other Study ID Numbers: 14-002660
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Curcumin
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
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