Primary Biliary Cirrhosis Clinical Trial
Official 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
Verified date | October 2019 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 20, 2018 |
Est. primary completion date | September 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Susanne Keiding | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Frisch K, Jakobsen S, Sørensen M, Munk OL, Alstrup AK, Ott P, Hofmann AF, Keiding S. [N-methyl-11C]cholylsarcosine, a novel bile acid tracer for PET/CT of hepatic excretory function: radiosynthesis and proof-of-concept studies in pigs. J Nucl Med. 2012 Ma — View Citation
Ørntoft NW, Munk OL, Frisch K, Ott P, Keiding S, Sørensen M. Hepatobiliary transport kinetics of the conjugated bile acid tracer (11)C-CSar quantified in healthy humans and patients by positron emission tomography. J Hepatol. 2017 Aug;67(2):321-327. doi: — View Citation
Sørensen M, Munk OL, Ørntoft NW, Frisch K, Andersen KJ, Mortensen FV, Alstrup AK, Ott P, Hofmann AF, Keiding S. Hepatobiliary Secretion Kinetics of Conjugated Bile Acids Measured in Pigs by 11C-Cholylsarcosine PET. J Nucl Med. 2016 Jun;57(6):961-6. doi: 1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of OCA on bile flow | Bile flow measured by PET | Measured after 3 months of treatment with Obeticholic Acid or placebo |
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