A Study Of Ursolic Acid For Primary Sclerosing Cholangitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03216876
• Date of registration: 05/01/2016
• Prospective Registration: Yes
• Primary sponsor: University of California, Davis
• Public title: A Study Of Ursolic Acid For Primary Sclerosing Cholangitis
• Scientific title: An Open-Label Study Of Ursolic Acid For Primary Sclerosing Cholangitis
• Date of first enrolment: September 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03216876
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Christopher Bowlus, MD
• Affiliation: University of California, Davis

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female age 18 - 70 years of age

- PSC documented by typically cholangiogram findings of strictures and dilations with no
evidence of a secondary cause of sclerosing cholangitis

- Serum alkaline phosphatase greater than 1.5 times the upper limit of the normal
reference range at the UC Davis Health Systems Clinical Laboratory

- AST and ALT = 10 x ULN

- Serum creatinine < 2.0 mg/dL

- Mayo Activity Index of < 2 (in those with ulcerative colitis or Crohn's colitis)

- Negative serum pregnancy test for female subjects of childbearing potential, agreement
to use a highly effective method of contraception during heterosexual intercourse
(females of childbearing potential), lactating females must agree to discontinue
nursing before starting study treatment, and barrier contraception during heterosexual
intercourse (males not vasectomized).

Exclusion Criteria:

- Pregnancy

- Hepatic decompensation defined as ascites (or use of diuretics), episodes of hepatic
encephalopathy, variceal bleeding or an INR > 1.2

- Positive HCV RNA or HBsAg, positive anti-mitochondrial antibody, alcohol consumption
greater than 21oz/week for males or 14oz/week for females

- Clinically significant cardiac disease, history of cholangiocarcinoma, history of
liver transplantation, history of cancers, other than non-melanomatous skin cancer,
within 5 years prior to screening

- Ascending cholangitis within 60 days of screening

- Use of immunosuppressants including 6-mercaptopurine, azathioprine, methotrexate,
mycophenolate mofetil, tacrolimus, cyclosporine, and anti-TNF or other biologics
within 6 months of enrollment

- Use of antibiotics including vancomycin, metronidazole, or rifaximin within 60 days of
enrollment



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Intervention(s)

Drug: Ursolic acid

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time Frame: 24 hours]

Secondary Outcome(s)

clearance [Time Frame: 24 hours]

C-reactive Protein (CRP) [Time Frame: 24 weks]

maximum plasma concentration (C¬max) [Time Frame: 24 hours]

Mayo Risk Score (MRS) [Time Frame: 24 weks]

volume of distribution (Vd) [Time Frame: 24 hours]

Alanine aminotransferase (ALT) [Time Frame: 24 weeks]

Area under the concentration-time curve (AUC) [Time Frame: 24 hours]

half-life (t1/2), [Time Frame: 24 hours]

Biochemical response [Time Frame: 24 weeks]

Total bilirubin [Time Frame: 24 weks]

Secondary ID(s)

PSC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors