Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
Public ClinicalTrials.gov record NCT02177136. 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 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Primary Sclerosing Cholangitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE) phase was conducted to evaluate the safety, tolerability, and efficacy of long-term, open-label use of OCA in participants with PSC who had completed the DB phase of the study.
Study identification
- NCT ID
- NCT02177136
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 77 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Feb 9, 2015 (Actual)
- Primary completion
- Mar 7, 2017 (Actual)
- Completion
- Mar 22, 2018 (Actual)
- Last update posted
- Jul 8, 2021
2015 – 2018
United States locations
- U.S. sites
- 33
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | — |
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of Colorado, Denver | Aurora | Colorado | 80045 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Piedmont Atlanta Georgia Transplant Institute | Atlanta | Georgia | 30309 | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Southern Therapy and Advanced Research | Jackson | Mississippi | 39216 | — |
| St. Louis University Gastroenterology & Hepatology | St Louis | Missouri | 63104 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas | 77030 | — |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| McGuire DVAMC | Richmond | Virginia | 23249 | — |
| Swedish Organ Transplant and 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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02177136, 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 Jul 8, 2021 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02177136 live on ClinicalTrials.gov.