A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
Public ClinicalTrials.gov record NCT05014672. 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
TRANSFORM: A 24-week, Randomized, Placebo-controlled, Double-blind, Phase 2b Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).
Study identification
- NCT ID
- NCT05014672
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Feb 14, 2022 (Actual)
- Primary completion
- May 31, 2024 (Actual)
- Completion
- Jul 2, 2024 (Actual)
- Last update posted
- Apr 24, 2025
2022 – 2024
United States locations
- U.S. sites
- 29
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UA Thomas D. Boyer Liver Institute | Tucson | Arizona | 85724 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| Gastroenterology Associates - Crystal River | Inverness | Florida | 34452 | — |
| University of Miami Leonard M. Miller School of Medicine | Miami | Florida | 33136 | — |
| AdventHealth Transplant Institute | Orlando | Florida | 32804 | — |
| Advanced Research Institute, Inc. | Orlando | Florida | 32825 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Northwestern University | Evanston | Illinois | 60611 | — |
| Springfield Clinic | Springfield | Illinois | 62794-9248 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Kansas Medical Clinic - Gastroenterology | Topeka | Kansas | 66606 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| A. Alfred Taubman Health Care Center | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Summit - Southern Therapy and Advanced Research | Jackson | Mississippi | 39216 | — |
| Northwell Health | Manhasset | New York | 11030 | — |
| New York University Hepatology Associates | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0595 | — |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | — |
| Vanderbilt Digestive Disease Center | Nashville | Tennessee | 37232 | — |
| Liver Specialists of Texas | Houston | Texas | 77030 | — |
| Pioneer Research Solutions | Houston | Texas | 77099 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Froedtert and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 99 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05014672, 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 Apr 24, 2025 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05014672 live on ClinicalTrials.gov.