A Study to Evaluate the Safety and Effectiveness of Using Curcumin for Patients with Primary Sclerosing Cholangitis

Overview

  • Study type

    Interventional
  • Study phase

    I/II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 14-002660
    • Rochester, Minnesota: 14-002660
    NCT ID: NCT02978339
    Sponsor Protocol Number: 14-002660

About this study

The purpose of this study is to evaluate the safety and effectiveness of curcumin used in patients with primary sclerosing cholangitis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elizabeth Carey, M.D.

Closed for enrollment

Contact information:

Michael Leonard

(480)342-2908

Leonard.Michael@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Nicholas LaRusso, M.D.

Open for enrollment

Contact information:

Linda Stadheim R.N.

.
CLS-20198645

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