Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
NCT ID: NCT01904058
Last Updated: 2019-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2013-08-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LUM001 and Ursodeoxycholic Acid (UDCA)
Administered orally once daily
LUM001
Ursodeoxycholic Acid
Placebo and Ursodeoxycholic Acid (UDCA)
Administered orally once daily
Placebo
Ursodeoxycholic Acid
Interventions
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LUM001
Placebo
Ursodeoxycholic Acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe pruritus
3. Taking ursodeoxycholic acid (UDCA) for at least 6 months, or unable to tolerate UDCA
4. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures
Exclusion Criteria
2. Liver transplant
3. Known HIV infection
4. Women who are pregnant or lactating
18 Years
80 Years
ALL
No
Sponsors
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Mirum Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Mirum
Locations
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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
Countries
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Related Links
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Related Info
Other Identifiers
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2013-000482-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LUM001-201
Identifier Type: -
Identifier Source: org_study_id
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