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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03216876
Other study ID # PSC-001
Secondary ID
Status Withdrawn
Phase Phase 1
First received January 5, 2016
Last updated July 21, 2017
Start date September 2017
Est. completion date July 2019

Study information

Verified date July 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, active treatment trial to determine the pharmacokinetics of orally administered ursolic acid and to assess the potential efficacy and safety of ursolic acid in subjects with primary sclerosing cholangitis (PSC).


Description:

In the first phase of this trial, 6 healthy subjects and 2 PSC subjects will assigned to ursolic acid taken orally as a single dose of 40 mg, 80 mg, and 120 mg to determine the optimal dose in humans.

The second phase of this trial will involve 20 PSC subjects assigned to treatment with daily oral ursolic acid at the dose determined to be optimal in the first phase of the study. The treatment will last for 24 weeks with an off-treatment follow up of 28 weeks.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Drug:
Ursolic acid
Ursolic acid (UA) is a natural triterpenoid carboxylic acid, which has been studied for its anti-proliferative and anti-inflammatory activities.

Locations

Country Name City State
United States Univeristy of California Davis Medical Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Number of serious adverse events or Grade 3-4 biochemical abnormalities 24 hours
Secondary maximum plasma concentration (C¬max) Measured in mass of drug/ volume of fluid, The peak plasma concentration of a drug after administration. 24 hours
Secondary half-life (t1/2), measured in time ,Time to reach Cmax. 24 hours
Secondary volume of distribution (Vd) Measured in volume, The apparent volume in which a drug is distributed (i.e., the parameter relating drug concentration to drug amount in the body). 24 hours
Secondary clearance Measured in Volume/ time, The volume of plasma cleared of the drug per unit time 24 hours
Secondary Area under the concentration-time curve (AUC) Measured in mass/(volume*time), The integral of the concentration-time curve (after a single dose or in steady state). 24 hours
Secondary Alanine aminotransferase (ALT) Change in ALT from baseline to 24 weeks 24 weeks
Secondary Total bilirubin Change in total bilirubin from baseline to 24 weeks. 24 weks
Secondary C-reactive Protein (CRP) Change in CRP from baseline to 24 weeks. 24 weks
Secondary Mayo Risk Score (MRS) Change in MRS from baseline to 24 weeks. 24 weks
Secondary Biochemical response Reduction in serum alkaline phosphatase by 50% or to within the normal reference range and change in alkaline phosphatase from day 0 to week 24. 24 weeks
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