Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/29/2019
Start Date:August 2013
End Date:April 2015

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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

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.


Inclusion Criteria:

1. Diagnosis of Primary Biliary Cirrhosis

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:

1. History or presence of other concomitant significant liver disease

2. Liver transplant

3. Known HIV infection

4. Women who are pregnant or lactating
We found this trial at
18
sites
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Detroit, Michigan 48202
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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New York, New York 10021
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Newport News, Virginia 23602
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Richmond, Virginia 23249
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Rochester, Minnesota 55905
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
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Saint Louis, Missouri 63110
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Saint Paul, Minnesota 55114
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Salt Lake City, Utah 84132
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