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

• Status: Completed
• Trial end date: 2018-09-20
• Target enrollment: 0
• Participant gender: All

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 OCA administration to patients with PBC increases hepatobiliary secretion of cholylsarcosine assessed by PET/CT using 11C-labeled cholylsarcosine (11C-CSar) as tracer.

The results of this research project will elucidate the mechanism of the effect of using OCA therapeutically in patients with PBC.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Bile Acids and Salts; Chenodeoxycholic Acid

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