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

An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis

Sponsors

Lead Sponsor: John E. Eaton

Collaborator: EuroPharma, Inc.

Source 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).

Overall Status Completed
Start Date 2017-06-09
Completion Date 2019-01-08
Primary Completion Date 2018-11-16
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Serum Alkaline Phosphatase (SAP) baseline, 12 weeks
Secondary Outcome
Measure Time Frame
Change in Serum Aspartate Aminotransferase (AST) Baseline, 12 weeks
Change in Total Bilirubin Baseline, 12 weeks
Change in C-Reactive Protein (CRP) Baseline, 12 weeks
Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score Baseline, 12 weeks
Change in Fatigue Severity Baseline, 12 weeks
Change in Pruritus Baseline, 12 weeks
Enrollment 15
Condition
Intervention

Intervention Type: Drug

Intervention Name: Curcumin

Description: 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.

Arm Group Label: Curcumin

Other Name: CuraMed® softgel

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Nicholas F LaRusso, M.D. Principal Investigator Mayo Clinic
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Mayo Clinic
Location Countries

United States

Verification Date

2020-01-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Mayo Clinic

Investigator Full Name: John E. Eaton

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Curcumin

Type: Experimental

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Sclerosing Cholangitis

Clinical Trials on Curcumin