Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03253276
• Date of registration: 28/05/2017
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT
• Scientific title: Effect of Obeticholic Acid (INT-747, Intercept) on the Hepatobiliary Transport of Bile Acids in Patients With PBC Examined by 11C-cholyl-sarcosine PET/CT
• Date of first enrolment: May 19, 2016
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03253276
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Early Phase 1

Countries of recruitment

Denmark

Contacts

• Name: Susanne Keiding, prof
• Affiliation: University of Aarhus

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- Itching that requires medical treatment



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Drug: Obeticholic acid

Drug: Placebos

Primary Outcome(s)

Effect of OCA on bile flow [Time Frame: Measured after 3 months of treatment with Obeticholic Acid or placebo]

Secondary ID(s)

OCAPBC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors