Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Public ClinicalTrials.gov record NCT01473524. 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, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).
Study identification
- NCT ID
- NCT01473524
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 217 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 31, 2011
- Primary completion
- Nov 30, 2013
- Completion
- Dec 16, 2018
- Last update posted
- May 5, 2021
2012 – 2018
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| Scripps Clinic | San Diego | California | 92037 | — |
| University of Colorado, Denver | Aurora | Colorado | 80045 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Henry Ford Health System | Detroit | Michigan | 48377 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Liver Institute of Virginia | Newport News | Virginia | 23602 | — |
| Liver Institute of Virginia | Richmond | Virginia | 23226 | — |
| Virginia Commonwealth University/McGuire DVAMC | Richmond | Virginia | 23249 | — |
| Swedish Medical Center | Seattle | Washington | 98101 | — |
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 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01473524, 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 May 5, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01473524 live on ClinicalTrials.gov.