Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Public ClinicalTrials.gov record NCT02308111. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.
Study identification
- NCT ID
- NCT02308111
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 334 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 26, 2014 (Actual)
- Primary completion
- Dec 23, 2021 (Actual)
- Completion
- Dec 23, 2021 (Actual)
- Last update posted
- Mar 9, 2023
2014 – 2021
United States locations
- U.S. sites
- 43
- U.S. states
- 23
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| University of California Davis, Davis Medical Center | Sacramento | California | 95817 | — |
| Stanford University | Stanford | California | 94304 | — |
| University of Colorado Denver and Hospital | Aurora | Colorado | 80045 | — |
| UF Hepatology Research at CTRB | Gainesville | Florida | 32610 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33163 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60637 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | — |
| University of Louisville, Medical Dental Complex | Louisville | Kentucky | 40202 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| UMass Medical School | Worcester | Massachusetts | 01655 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Minnesota Gastroenterology, P.A. | Saint Paul | Minnesota | 55114 | — |
| Southern Therapy and Advanced Research (STAR) | Jackson | Mississippi | 39216 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Saint Louis University Gastroenterology & Hepatology | St Louis | Missouri | 63104 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Quality Medical Research, PLLC | Nashville | Tennessee | 37211 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Texas Digestive Disease Consultants | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Baylor Scott and White Research Institute | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | — |
| UT Health The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| Clinical Research Centers of America | Murray | Utah | 84123 | — |
| McGuire DVAMC | Richmond | Virginia | 23249 | — |
| Swedish Organ Transplant & Liver Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 138 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02308111, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 9, 2023 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02308111 live on ClinicalTrials.gov.