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

NCT02978339 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 14-002660
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• Change in Serum Alkaline Phosphatase (SAP)

  Number of subjects who experience a reduction of Serum Alkaline Phosphatase (SAP) to less than 1.5 x Upper Limit of Normal or a 40% reduction between baseline and week 12.

  baseline, 12 weeks

Secondary Outcomes (6)

• 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

Study Arms (1)

Curcumin

EXPERIMENTAL

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

Interventions

Curcumin DRUG

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.

Also known as: CuraMed® softgel

Curcumin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• John E. Eaton: lead
• EuroPharma, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: John E. Eaton, M.D.
• Organization: Mayo Clinic

Eaton.John@mayo.edu

507-284-3917

Study Officials

• Nicholas F LaRusso, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 30, 2016
• Study Start: June 9, 2017
• Primary Completion: November 16, 2018
• Study Completion: January 8, 2019
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Locations

US (1)