Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
Public ClinicalTrials.gov record NCT03226067. 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 Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).
Study identification
- NCT ID
- NCT03226067
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 111 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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
- Jun 26, 2017 (Actual)
- Primary completion
- Apr 11, 2019 (Actual)
- Completion
- Apr 11, 2019 (Actual)
- Last update posted
- Jun 29, 2022
2017 – 2019
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| University California Davis | Sacramento | California | 95817 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| Yale School of Medicine | New Haven | Connecticut | 06520-8019 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| Jackson Liver and GI Specialist c/o (STAR) LLC | Jackson | Mississippi | 39216 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| NYU Hepatology Associates | New York | New York | 10016 | — |
| Mount Sinai Health System | New York | New York | 10029 | — |
| University of Rochester Medical Centre | Rochester | New York | 14642 | — |
| Dayton Gastroenterology Inc. | Beavercreek | Ohio | 45440 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| UPMC Center for Liver Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| Methodist University Hospital | Memphis | Tennessee | 38104 | — |
| St Lukes Episcopal Hospital | Houston | Texas | 77030 | — |
| Pinnacle Clinical Research, PLLC | Live Oak | Texas | 78233 | — |
| Bon Secours Liver Institute of Hampton Roads | Newport News | Virginia | 23602 | — |
| Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
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 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03226067, 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 Jun 29, 2022 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03226067 live on ClinicalTrials.gov.