Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2023
• Main ID: NCT03602976
• Date of registration: 19/07/2018
• Prospective Registration: Yes
• Primary sponsor: Ethan Weinberg
• Public title: Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis
• Scientific title: A Single-center, Open Label, Cross-over Study on the Effects of Ursodeoxycholic Acid (UDCA) in Patients With Hepatic Sarcoidosis
• Date of first enrolment: August 20, 2018
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03602976
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatic Sarcoidosis, Elevated Alkaline Phosphatase

Intervention(s)

Drug: Ursodeoxycholic Acid

Primary Outcome(s)

Alkaline Phosphatase (U/L) or Gamma Glutamyl Transferase (U/L) 6 Months After Initiation of Ursodeoxycholic Acid [Time Frame: 6 months after initiaiton of UDCA]

Secondary Outcome(s)

AST [Time Frame: Baseline and 6 months after initiation of UDCA]

ALT [Time Frame: Baseline and 6 months after initiation of UDCA]

Bilirubin [Time Frame: Baseline and 6 months after initiation of UDCA]

Liver Stiffness [Time Frame: Baseline and 6 months after initiation of UDCA]

Secondary ID(s)

828780

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Meridian Bioscience, Inc.

American Association for the Study of Liver Diseases

Results

• Results available: Yes
• Date Posted: 07/06/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03602976