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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02978339
• Date of registration: 22/11/2016
• Prospective Registration: Yes
• Primary sponsor: John E. Eaton
• Public title: A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
• Scientific title: An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis
• Date of first enrolment: June 9, 2017
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02978339
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Nicholas F LaRusso, M.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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, a1-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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Intervention(s)

Drug: Curcumin

Primary Outcome(s)

Change in Serum Alkaline Phosphatase (SAP) [Time Frame: baseline, 12 weeks]

Secondary Outcome(s)

Change in Fatigue Severity [Time Frame: Baseline, 12 weeks]

Change in C-Reactive Protein (CRP) [Time Frame: Baseline, 12 weeks]

Change in Pruritus [Time Frame: Baseline, 12 weeks]

Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score [Time Frame: Baseline, 12 weeks]

Change in Total Bilirubin [Time Frame: Baseline, 12 weeks]

Change in Serum Aspartate Aminotransferase (AST) [Time Frame: Baseline, 12 weeks]

Secondary ID(s)

14-002660

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

EuroPharma, Inc.

Results

• Results available: Yes
• Date Posted: 18/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02978339