A Single-center, Open Label, Cross-over Study on the Effects of Ursodeoxycholic Acid (UDCA) in Patients With Hepatic Sarcoidosis

828780

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.

2018-08-20

2022-01-12

2022-01-12

Terminated

Early phase I

7

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects will act as their own controls by undergoing a six-month initial observational period prior to initiating the six-month UDCA intervention', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All subjects will receive appropriately dosed UDCA after six months of observation'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

2023-06-07