Hepatic Sarcoidosis, Elevated Alkaline Phosphatase Clinical Trial
Official title:
A Single-center, Open Label, Cross-over Study on the Effects of Ursodeoxycholic Acid (UDCA) in Patients With Hepatic Sarcoidosis
Verified date | June 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 12, 2022 |
Est. primary completion date | January 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Ethan Weinberg | American Association for the Study of Liver Diseases, Meridian Bioscience, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alkaline Phosphatase (U/L) or Gamma Glutamyl Transferase (U/L) 6 Months After Initiation of Ursodeoxycholic Acid | Alkaline Phosphatase (U/L) or Gamma Glutamyl Transferase (U/L) 6 months after initiation of ursodeoxycholic acid | 6 months after initiaiton of UDCA | |
Secondary | Liver Stiffness | kPa as assessed by Fibroscan | Baseline and 6 months after initiation of UDCA | |
Secondary | Bilirubin | Baseline and 6 months after initiation of UDCA | ||
Secondary | AST | Baseline and 6 months after initiation of UDCA | ||
Secondary | ALT | Baseline and 6 months after initiation of UDCA |