Phase 2
N=15
A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
Bottom Line
View on ClinicalTrials.gov: NCT02978339 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in Serum Alkaline Phosphatase (SAP) — 3 Participants — p=.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Curcumin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- John E. Eaton
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Alkaline Phosphatase (SAP) |
3 | .03 sig |
| SECONDARY Change in Serum Aspartate Aminotransferase (AST) |
78 | 0.59 |
| SECONDARY Change in Total Bilirubin |
0.6 | 0.91 |
| SECONDARY Change in C-Reactive Protein (CRP) |
3.4 | 0.41 |
| SECONDARY Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score |
0.54 | .15 |
| SECONDARY Change in Fatigue Severity |
8.00 | .06 |
| SECONDARY Change in Pruritus |
8.00 | .93 |
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.
Data sourced from ClinicalTrials.gov (NCT02978339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.