Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
Public ClinicalTrials.gov record NCT01904058. 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, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.
Study identification
- NCT ID
- NCT01904058
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 66 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
- Jul 31, 2013
- Primary completion
- Mar 31, 2015
- Completion
- Mar 31, 2015
- Last update posted
- Mar 26, 2019
2013 – 2015
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | — |
| University of California at Davis | Sacramento | California | 95817 | — |
| University of Miami | Miami | Florida | 33136 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Minnesota Gastroenterology | Saint Paul | Minnesota | 55114 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Advanced Liver Therapies at St. Lukes Episcopal Hospital | Houston | Texas | 77030 | — |
| University of Utah Health Science Center | Salt Lake City | Utah | 84132 | — |
| Liver Institute of Virginia | Newport News | Virginia | 23602 | — |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| University of Washington Harborview Medical Center | Seattle | Washington | 98104 | — |
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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01904058, 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 Mar 26, 2019 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01904058 live on ClinicalTrials.gov.