NCT03253276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2016

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

May 28, 2017

Last Update Submit

October 31, 2019

Conditions

Primary Biliary Cirrhosis

Keywords

Bile Acid Transporter

Outcome Measures

Primary Outcomes (1)

  • Effect of OCA on bile flow

    Bile flow measured by PET

    Measured after 3 months of treatment with Obeticholic Acid or placebo

Study Arms (2)

Obeticholic Acid

ACTIVE COMPARATOR

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

placebos

PLACEBO COMPARATOR

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

Interventions

Obeticholic acidDRUG

Placebo-controlled

Also known as: placebo
Obeticholic Acid
PlacebosDRUG
Also known as: Obeticholic acid
placebos

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Itching that requires medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Susanne Keiding

Aarhus, 8000, Denmark

Location

Related Publications (4)

  • Orntoft NW, Munk OL, Frisch K, Ott P, Keiding S, Sorensen M. Hepatobiliary transport kinetics of the conjugated bile acid tracer 11C-CSar quantified in healthy humans and patients by positron emission tomography. J Hepatol. 2017 Aug;67(2):321-327. doi: 10.1016/j.jhep.2017.02.023. Epub 2017 Feb 27.

    PMID: 28249726RESULT

  • Sorensen M, Munk OL, Orntoft 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: 10.2967/jnumed.115.171579. Epub 2016 Mar 10.

    PMID: 26966160RESULT

  • Frisch K, Jakobsen S, Sorensen 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 May;53(5):772-8. doi: 10.2967/jnumed.111.098731. Epub 2012 Mar 27.

    PMID: 22454486RESULT

  • Kjaergaard K, Frisch K, Sorensen M, Munk OL, Hofmann AF, Horsager J, Schacht AC, Erickson M, Shapiro D, Keiding S. Obeticholic acid improves hepatic bile acid excretion in patients with primary biliary cholangitis. J Hepatol. 2021 Jan;74(1):58-65. doi: 10.1016/j.jhep.2020.07.028. Epub 2020 Jul 25.

    PMID: 32717289DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susanne Keiding, prof

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Codes (OCA or placebo) will be opened after final examination of final patient
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Double blind placebo-controlled crossover
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2017

First Posted

August 17, 2017

Study Start

May 19, 2016

Primary Completion

September 20, 2018

Study Completion

September 20, 2018

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)