ClinicalTrials.gov record
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
ClinicalTrials.gov ID: NCT03439254
Public ClinicalTrials.gov record NCT03439254. 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 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Study identification
- NCT ID
- NCT03439254
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 919 participants
Conditions and interventions
Interventions
- Obeticholic acid (10 mg) Drug
- Obeticholic acid (10 mg to 25 mg) Drug
- Placebo Drug
Drug
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
- Aug 30, 2017 (Actual)
- Primary completion
- Sep 8, 2022 (Actual)
- Completion
- Sep 8, 2022 (Actual)
- Last update posted
- Oct 23, 2023
2017 – 2022
United States locations
- U.S. sites
- 120
- U.S. states
- 34
- U.S. cities
- 99
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Objective GI d/b/a North Alabama GI Research Center | Madison | Alabama | 35758 | — |
| Arizona Liver Health | Chandler | Arizona | 85224 | — |
| Arizona Liver Health | Glendale | Arizona | 85306 | — |
| The Institute for Liver Health | Tucson | Arizona | 85712 | — |
| Liver Wellness Center | Little Rock | Arkansas | 72205 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| Hope Clinical Research | Canoga Park | California | 91303 | — |
| University of California, San Francisco-Fresno | Fresno | California | 93701 | — |
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 | — |
| eStudySite | La Mesa | California | 91942 | — |
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| Cedars-Sinani Medical Center | Los Angeles | California | 90048 | — |
| Palmtree Clinical Research, INC. | Palm Springs | California | 92262 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| University of Colorado Denver and Hospital | Aurora | Colorado | 80045 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | — |
| Innovative Medical Research of South Florida, Inc. | Aventura | Florida | 33180 | — |
| Hi Tech and Global Research LLC | Coral Gables | Florida | 33134 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| UF Health Jacksonville-Gastroenterology Emerson | Jacksonville | Florida | 32207 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| Sensible Healthcare, LLC | Ocoee | Florida | 34761 | — |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | — |
| Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | 32503 | — |
| Tampa General Medical Group | Tampa | Florida | 33606 | — |
| Guardian Angel Research Center, INC | Tampa | Florida | 33614 | — |
| Florida Medical Clinic, P.A | Zephyrhills | Florida | 33542 | — |
| Summit Clinical Research, LLC | Athens | Georgia | 30607 | — |
| The Emory Clinic (TEC) | Atlanta | Georgia | 30322 | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | — |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | 83404 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Aquiant Research | New Albany | Indiana | 47150 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Kansas Medical Clinic | Topeka | Kansas | 66606 | — |
| University of Louisville, Clinical Trials Unit | Louisville | Kentucky | 40202 | — |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | — |
| Delta Research Partners, LLC | Monroe | Louisiana | 71201 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Louisiana Research Center | Shreveport | Louisiana | 71105 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | — |
| UMass Memorial Health Care | Worcester | Massachusetts | 01655 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | — |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | — |
| Minnesota Gastroenterology, P.A. | Saint Paul | Minnesota | 55114 | — |
| Southern Therapy and Advanced Research (STAR) LLC | Jackson | Mississippi | 39216 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| CHI Health Alegent Creighton Clinic | Omaha | Nebraska | 68124 | — |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | — |
| Amici GI-LLC | Martinsville | New Jersey | 08836 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| University at Buffalo, Clinical and Translational Research Center | Buffalo | New York | 14203 | — |
| Ichan School of Medicine at Mount Sinai Beth Israel | New York | New York | 10003 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | — |
| University of North Carolina at Chapel Hill, School of Medicine | Chapel Hill | North Carolina | 27599 | — |
| Charlotte Gastroenterology & Hepatology, PLLC | Charlotte | North Carolina | 28207 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Carolinas Center for Liver Disease/Carolinas HealthCare System | Huntersville | North Carolina | 28078 | — |
| Carolinas Health Care System Center for Liver Disease | Huntersville | North Carolina | 28078 | — |
| Diabetes & Endocrinology Consultants, PC | Morehead City | North Carolina | 28557 | — |
| Trial Management Associates, LLC | Wilmington | North Carolina | 28403 | — |
| Dayton Gastroenterology, Inc. | Beavercreek | Ohio | 45440 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | — |
| The Pennsylvania State University and the Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | — |
| UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute | Pittsburgh | Pennsylvania | 15213 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Ralph H. Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | — |
| SCTR Research Nexus | Charleston | South Carolina | 29425 | — |
| Rapid City Medical Center LLP | Rapid City | South Dakota | 57701 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Associates in Gastroenterology, PLC | Hermitage | Tennessee | 37076 | — |
| Johnson City Medical Center | Johnson City | Tennessee | 37604 | — |
| Methodist Healthcare University Hospital | Memphis | Tennessee | 38104 | — |
| Quaility Medical Research, PLLC | Nashville | Tennessee | 37211 | — |
| Vanderbilt University Medical Center - Digestive Disease Center | Nashville | Tennessee | 37232 | — |
| Texas Clinical Research Institute LLC | Arlington | Texas | 76012 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Liver Center of Texas | Dallas | Texas | 75234 | — |
| Texas Digestive Disease Consultants | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Baylor Scott and White All Saints Medical Center | Fort Worth | Texas | 76104 | — |
| Texas Digestive Disease Consultants | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | — |
| The University of Texas Medical School at Houston | Houston | Texas | 77030 | — |
| Centex Studies, Inc. | McAllen | Texas | 78504 | — |
| American Research Corporation | San Antonio | Texas | 78215 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants | San Marcos | Texas | 78666 | — |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads | Newport News | Virginia | 23602 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours | Richmond | Virginia | 23226 | — |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Gastroenterology Consultants of Southwest Virginia | Roanoke | Virginia | 24014 | — |
| Virginia Mason - Seattle Medical Center | Seattle | Washington | 98101 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
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 72 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03439254, 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 Oct 23, 2023 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03439254 live on ClinicalTrials.gov.