A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
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Official title
A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
Study identification
- NCT ID
- NCT03394924
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 68 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
- Dec 27, 2017 (Actual)
- Primary completion
- Dec 19, 2019 (Actual)
- Completion
- Jan 16, 2020 (Actual)
- Last update posted
- May 18, 2021
2017 – 2020
United States locations
- U.S. sites
- 40
- U.S. states
- 20
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Arkansas Diagnostic Center | Little Rock | Arkansas | 72205 | — |
| Texas Clinical Research Institute | Little Rock | Arkansas | 76012 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| California Liver Research Institue | Pasadena | California | 91105 | — |
| Pasadena Liver Center | Pasadena | California | 91105 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| South Denver Gastroenterology - Swedish Medical Center Office | Englewood | Colorado | 80113 | — |
| Yale School of Medicine | New Haven | Connecticut | 06520 | — |
| Gastroenterology Consultants of Clearwater | Clearwater | Florida | 33756-3839 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| University of Miami Leonard M. Miller School of Medicine | Miami | Florida | 33136 | — |
| Consultative Gastroenterology | Atlanta | Georgia | 30312 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Louisiana Research Center | Shreveport | Louisiana | 71105 | — |
| Mercy Medical Center-McAuley Plaza | Baltimore | Maryland | 21202 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Digestive Disease Associates | Catonsville | Maryland | 21228 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Hospital | Detroit | Michigan | 48377 | — |
| CHI Health | Omaha | Nebraska | 68124 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Northwell Health | Manhasset | New York | 11030 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| Mount Sinai Beth Isreal | New York | New York | 10016 | — |
| Weill Cornell Medical College | New York | New York | 10024 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Montefiore Medical Center - Bronx | The Bronx | New York | 10461-1925 | — |
| University of Pittsburgh Medical Center - Center for Liver Disease | Pittsburgh | Pennsylvania | 15213 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Liver Consultants of Texas | Dallas | Texas | 76104 | — |
| Baylor Saint Luke's Medical Center | Houston | Texas | 77030 | — |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Liver Institute of Virginia-Bremo | Richmond | Virginia | 23602 | — |
| Swedish First Hill Campus | Seattle | Washington | 98104 | — |
| University of Washington | Seattle | Washington | 98195-6460 | — |
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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03394924, 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 18, 2021 · Synced Nov 14, 2026
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