A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
Public ClinicalTrials.gov record NCT03394924. 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 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)
Study identification
- NCT ID
- NCT03394924
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Industry
- Enrollment
- 68 participants
Conditions and interventions
Conditions
Interventions
- EDP-305 1 mg Drug
- EDP-305 2.5 mg Drug
- Placebo Drug
Drug
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 26, 2017
- Primary completion
- Dec 18, 2019
- Completion
- Jan 15, 2020
- Last update posted
- May 17, 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 17, 2021 · Synced Jul 24, 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 protocol, eligibility criteria, and contact information for NCT03394924 live on ClinicalTrials.gov.