ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Public ClinicalTrials.gov record NCT03602560. 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 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Study identification
- NCT ID
- NCT03602560
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 265 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
- Oct 1, 2018 (Actual)
- Primary completion
- Feb 16, 2020 (Actual)
- Completion
- Feb 16, 2020 (Actual)
- Last update posted
- Aug 2, 2022
2018 – 2020
United States locations
- U.S. sites
- 51
- U.S. states
- 24
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Institute for Liver Health | Chandler | Arizona | 85224 | — |
| Mayo Clinic Arizona - PPDS | Phoenix | Arizona | 85054 | — |
| The Institute for Liver Health-Tucson | Tucson | Arizona | 85711 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Stanford University School of Medicine | Redwood City | California | 94063 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Univeristy of Colorado Denver and Hospital | Aurora | Colorado | 80045 | — |
| Yale School of Medicine Digestive Diseases, Internal Medicine | New Haven | Connecticut | 06510 | — |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | — |
| Florida Reserach Institute | Lakewood Rch | Florida | 34211 | — |
| Schiff Center for Liver Diseases University of Miami | Miami | Florida | 33136 | — |
| Tampa General Medical Group | Tampa | Florida | 33606 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02114 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Minnesota Gastroenterlogy, P.A. | Maplewood | Minnesota | 55117 | — |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | — |
| Southern Therapy and Advance Research (STAR) LLC | Jackson | Mississippi | 39216 | — |
| Digestive Health Specialists PA | Tupelo | Mississippi | 38801 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Center for Liver Disease and Transplantation | New York | New York | 10032 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A. | Asheville | North Carolina | 28801 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| UH Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| GIA Clinical Trials, LLC | Knoxville | Tennessee | 37909 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Liver Institute at Methodist Dallas | Dallas | Texas | 75203 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Digestive Disease Consultants | Fort Worth | Texas | 76104 | — |
| American Research Corporation | Houston | Texas | 77030 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| Mary Immaculate Hospital | Newport News | Virginia | 23602 | — |
| Bon Secours Richmond Community Hospital | Richmond | Virginia | 23226 | — |
| Swedish Medical 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 105 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03602560, 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 Aug 2, 2022 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03602560 live on ClinicalTrials.gov.