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

NCT03253276 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-11-01

No results posted yet for this study

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.

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

Obeticholic acid

Placebo-controlled

DRUG

Placebos

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Susanne Keiding, prof · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-19
Primary Completion
2018-09-20
Completion
2018-09-20

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253276 on ClinicalTrials.gov