Status:
COMPLETED
Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT
Lead Sponsor:
University of Aarhus
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
Brief Summary
This is an investigator-initiated, double-blind crossover study on the mechanism of OCA treatment of patients with PBC. Hypothesis and significance The investigators will test the hypothesis that OC...
Detailed Description
Background Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease characterized by cholestasis and cirrhosis. Pathogenesis comprises impaired hepatobiliary secretion of bile acids to...
Eligibility Criteria
Inclusion
- patients with PBC
- who are not responding adequately to treatment with UDCA, defined as ALP \> 2 times upper normal level during a time period of 6 months
Exclusion
- Itching that requires medical treatment
Key Trial Info
Start Date :
May 19 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03253276
Start Date
May 19 2016
End Date
September 20 2018
Last Update
November 1 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Susanne Keiding
Aarhus, Denmark, 8000