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

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ClinicalTrials.gov Identifier: NCT03253276
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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 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.


Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Obeticholic acid Drug: Placebos Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double blind placebo-controlled crossover
Masking: Double (Participant, Investigator)
Masking Description: Codes (OCA or placebo) will be opened after final examination of final patient
Primary Purpose: Basic Science
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
Actual Study Start Date : May 19, 2016
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018


Arm Intervention/treatment
Active Comparator: Obeticholic Acid
Patients with primary biliary cirrhosis are treated 3 months with OCA (active drug) or placebo in a double-blind cross-over study design.
Drug: Obeticholic acid
Placebo-controlled
Other Name: placebo

Placebo Comparator: placebos
Patients with primary biliary cirrhosis are treated 3 months with OCA (active drug) or placebo in a double-blind cross-over study design.
Drug: Placebos
Other Name: Obeticholic acid




Primary Outcome Measures :
  1. Effect of OCA on bile flow [ Time Frame: Measured after 3 months of treatment with Obeticholic Acid or placebo ]
    Bile flow measured by PET



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253276


Locations
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Denmark
Susanne Keiding
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Susanne Keiding, prof University of Aarhus
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03253276    
Other Study ID Numbers: OCAPBC
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Aarhus:
Bile Acid Transporter
Additional relevant MeSH terms:
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Liver Cirrhosis, Biliary
Fibrosis
Pathologic Processes
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Liver Cirrhosis
Chenodeoxycholic Acid
Cathartics
Gastrointestinal Agents