Clinical trial NCT02978339: A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
Official title: An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: EuroPharma, Inc.
First posted: 2016-11-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in Serum Alkaline Phosphatase (SAP)
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in Serum Aspartate Aminotransferase (AST)
timeFrame: Baseline, 12 weeks
measure: Change in Total Bilirubin
timeFrame: Baseline, 12 weeks
measure: Change in C-Reactive Protein (CRP)
timeFrame: Baseline, 12 weeks
measure: Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score
timeFrame: Baseline, 12 weeks
measure: Change in Fatigue Severity
timeFrame: Baseline, 12 weeks
measure: Change in Pruritus
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicholas F LaRusso, M.D.
role: PRINCIPAL_INVESTIGATOR
References: