RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Public ClinicalTrials.gov record NCT04620733. 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
RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients 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.
The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of treatment on the symptoms of PBC, including pruritus.
Study identification
- NCT ID
- NCT04620733
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 193 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
- Apr 21, 2021 (Actual)
- Primary completion
- Aug 11, 2023 (Actual)
- Completion
- Aug 11, 2023 (Actual)
- Last update posted
- Sep 5, 2024
2021 – 2023
United States locations
- U.S. sites
- 40
- U.S. states
- 21
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Institute for Liver Health DBA Arizona Liver Health | Chandler | Arizona | 85224 | — |
| Arkansas Diagnostic Center | Little Rock | Arkansas | 72205 | — |
| Stanford University School of Medicine | Palo Alto | California | 94305 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| California Pacific Medical Center - Sutter Pacific Medical Foundation | San Francisco | California | 94109 | — |
| Covenant Metabolic Specialists, LLC | Fort Myers | Florida | 33912 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| Covenant Research and Clinics, LLC | Sarasota | Florida | 34240 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| MNGI Digestive Health, P.A. | Maplewood | Minnesota | 55117 | — |
| Southern Therapy and Advanced Research, LLC (STAR) | Jackson | Mississippi | 39216 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| NYU Langone Health / NYU Grossman School of Medicine | New York | New York | 10016 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Care Access Research - Lumberton | Lumberton | North Carolina | 28358 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| UPMC Center for Liver Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| Galen Hepatology | Chattanooga | Tennessee | 37421 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt Digestive Disease Center | Nashville | Tennessee | 37212 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Digestive Disease Consultants dba GI Alliance | Fort Hood | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Pinnacle Clinical Research, PLLC | San Antonio | Texas | 78229 | — |
| Bon Secours Richmond Community Hospital LLC | Richmond | Virginia | 23226 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
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 94 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04620733, 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 Sep 5, 2024 · Synced Oct 20, 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 NCT04620733 live on ClinicalTrials.gov.