Biliary Cirrhosis, PrimaryNCT02932449
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
An observational study of Biliary Cirrhosis, Primary, run by Target PharmaSolutions, Inc. at 39 sites in United States.
Trial summary
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Cirrhosis, Primary
- How many people
- 711 participants
- Where
- 39 sitesUnited States
- Study dates
- Oct 2016to 23 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults with PBC who are being seen specifically to address this disease process
Who may be able to join
- Adult patients (age 18 or older) being treated or managed for PBC
Who cannot join
- Inability to provide written informed consent
- Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
University of Michigan
Ann Arbor, Michigan, 48109
Illinois Gastroenterology Group
Arlington Heights, Illinois, 60005
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045
Mercy Medical Center, GI Research
Baltimore, Maryland, 21202
Institute for Liver Health
Chandler, Arizona, 85224
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Center for Liver Disease and Transplant at CMC
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Gastro Florida
Clearwater, Florida, 33762
Ohio State University Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Baylor,Scott and White All Saints
Fort Worth, Texas
University of Florida Hepatology Research
Gainesville, Florida, 32610
Liver Associates of Texas, P.A.
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Southern Therapy and Advanced Research LLC (STAR)
Jackson, Mississippi, 39216
University of Arkansas
Little Rock, Arkansas, 72204
Pinnacle Clinical Research
Live Oak, Texas, 78233
University of Wisconsin
Madison, Wisconsin, 53705
Sandra Atlas Bass Center for Liver Diseases
Manhasset, New York, 11030
SCFLD/University of Miami
Miami, Florida, 33136
Yale Internal Medicine, Digestive Diseases
New Haven, Connecticut, 06520
NYU Langone Health
New York, New York, 10016
Weill Cornell Medical College
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
University of Nebraska
Omaha, Nebraska, 68106
Stanford University Medical Center
Palo Alto, California, 94304
California Liver Research Institute
Pasadena, California, 91105
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner University Medical Center
Phoenix, Arizona, 85006
Mayo Clinic
Phoenix, Arizona, 85054
Bon Secours Liver Institute of Virginia
Richmond, Virginia, 23226
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23298
University of California Davis
Sacramento, California, 95817
University of Washington
Seattle, Washington, 98104
Saint Louis University
St Louis, Missouri, 63104
About this study
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
- Conditions
- Biliary Cirrhosis, Primary
- Medical subject headings
- Liver Cirrhosis, Biliary
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate PBC treatment regimens being used in clinical practice
Measured: up to 5 years
Examine populations underrepresented in phase III clinical trials
Measured: up to 5 years
Examine biochemical response and its association with long term outcomes
Measured: up to 5 years
Estimate adverse event frequency and severity and describe management practices
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Cirrhosis, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932449
- Sponsor's protocol ID
- TARGET-PBC
- Status last verified
- Feb 2026
- First submitted
- 7 Sep 2016
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT02932449
- Acronym / sponsor ID
- TARGET-PBC
- Conditions
- Biliary Cirrhosis, Primary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with PBC who are being seen specifically to address this disease process
Key inclusion criteria (1 listed)
- Adult patients (age 18 or older) being treated or managed for PBC
Key exclusion criteria (2 listed)
- Inability to provide written informed consent
- Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate PBC treatment regimens being used in clinical practice
Time frame: up to 5 years
Examine populations underrepresented in phase III clinical trials
Time frame: up to 5 years
Examine biochemical response and its association with long term outcomes
Time frame: up to 5 years
Estimate adverse event frequency and severity and describe management practices
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Cirrhosis, Primary, run by Target PharmaSolutions, Inc. at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate PBC treatment regimens being used in clinical practice (time frame: up to 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.