Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
Completed · Phase 2 · Has a placebo group
Conditions studied: PBC, Primary Biliary Cirrhosis
In brief
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.
Key facts
- Study ID
- NCT01904058
- Run by
- Mirum Pharmaceuticals, Inc.
- People needed
- 66
- Starts
- 2013-08-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2019-03-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Primary Biliary Cirrhosis
- Moderate to severe pruritus
- Taking ursodeoxycholic acid (UDCA) for at least 6 months, or unable to tolerate UDCA
- Ability to understand and willingness to sign informed consent prior to initiation of any study procedures
You may not qualify if…
- History or presence of other concomitant significant liver disease
- Liver transplant
- Known HIV infection
- Women who are pregnant or lactating
Where it is running
- Scripps Clinic — La Jolla, California, United States
- University of California at Davis — Sacramento, California, United States
- University of Miami — Miami, Florida, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Louisville — Louisville, Kentucky, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Minnesota Gastroenterology — Saint Paul, Minnesota, United States
- St. Louis University — St Louis, Missouri, United States
- Weill Cornell Medical College — New York, New York, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Advanced Liver Therapies at St. Lukes Episcopal Hospital — Houston, Texas, United States
- University of Utah Health Science Center — Salt Lake City, Utah, United States
- Liver Institute of Virginia — Newport News, Virginia, United States
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
- University of Washington Harborview Medical Center — Seattle, Washington, United States
- University Health Network, Toronto Western Hospital — Toronto, Ontario, Canada
- University of Birmingham — Birmingham, England, United Kingdom
- Royal Liverpool & Broadgreen University Hospital — Liverpool, England, United Kingdom
- Newcastle University — Newcastle upon Tyne, England, United Kingdom
- Oxford University Hospitals (John Radcliffe) — Oxford, England, United Kingdom
- Royal Free Hospital — London, United Kingdom
- Imperial College London St Mary's Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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