A Study Of Ursolic Acid For Primary Sclerosing Cholangitis

• Status: Withdrawn
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Treatments: Ursolic acid

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