Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to (1) evaluate efficacy of UDCA in improving liver function and quality of life; (2) monitor safety, tolerability of UDCA, as well as progression of hepatic sarcoidosis and liver disease, in patients diagnosed with hepatic sarcoidosis. A minimum of 10 subjects will be followed for 12 months. For all subjects, initial 6 months will be observational; in subsequent 6 months, UDCA will be administered. Visits will occur every 3 months and involve routine blood collection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ethan Weinberg
• Collaborators: American Association for the Study of Liver Diseases; Exalenz Bioscience LTD.
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

1. Systemic sarcoidosis with evidence of liver involvement as denoted by any of the following:

• Elevated liver-specific alkaline phosphatase

• Granulomas on liver biopsy

• Hepatomegaly on imaging

• Portal Hypertension (via imaging or endoscopy)

2. Stable dose of immunosuppressant, if taking (no dose variation for 6 months)

3. If cirrhotic, absence of hepatocellular carcinoma as indicated by imaging within 6 months of screening

Exclusion Criteria:

1. Female who is pregnant, planning to become pregnant during the study, or breastfeeding

2. Clinically significant abnormalities, co-morbidities, or recent alcohol/drug abuse that make the subject an unsuitable candidate

3. Concurrent liver disease including hepatitis B, hepatitis C, alcohol-related liver disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis

4. Currently on UDCA

5. Prior intolerance to UDCA

6. Receipt of any investigational product within a time period equal to 10 half-lives of the product, or 6 weeks (whichever is longer), to study drug administration

7. Current evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites). In the event potential participant is post-transplant, no evidence of hepatic decompensation since transplantation