Loading clinical trials...

A Study Of Ursolic Acid For Primary Sclerosing Cholangitis | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

A Study Of Ursolic Acid For Primary Sclerosing Cholangitis

An Open-Label Study Of Ursolic Acid For Primary Sclerosing Cholangitis

NCT03216876•University of California, Davis

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).

Detailed 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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Univeristy of California Davis Medical Center

Sacramento, California, United States

Key Dates

Start Date

September 1, 2017

Primary Completion Date

January 1, 2019

Completion Date

July 1, 2019

Last Updated

July 25, 2017

Conditions

Primary Sclerosing Cholangitis

Interventions

Ursolic acid

DRUG

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

NCT04753996

Primary Sclerosing CholangitisPSC+1 more

View study

RECRUITING

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

NCT05750498

Autoimmune HepatitisPrimary Sclerosing Cholangitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Of Ursolic Acid For Primary Sclerosing Cholangitis

Inclusion Criteria

Exclusion Criteria

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Liver Cirrhosis Network Cohort Study

S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)