An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis



Status:Withdrawn
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:May 2015
End Date:March 2018

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An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Tolerability of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Biliary Cirrhosis

Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to
evaluate the long-term safety and tolerability of daily dosing with LUM001.

This is an open-label study in subjects with PBC who previously completed the LUM001 201
(CLARITY) study. The study is designed to investigate the long-term safety and tolerability
of LUM001 treatment, with daily dosing for up to 2 years. Changes over time, compared to
baseline, in liver enzymes, other biochemical markers associated with PBC, pruritus, and
other quality of life measures will also be assessed.

Inclusion Criteria:

1. Completed a core treatment protocol of LUM001 in the treatment of Primary Biliary
Cirrhosis.

2. Ability to understand and willingness to sign informed consent/assent prior to
initiation of any study procedures.

Exclusion Criteria:

1. Presence of advanced liver disease.

2. History of non-adherence during the subject's participation in the core LUM001
treatment protocol.
We found this trial at
14
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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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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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Indianapolis, IN
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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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142 Edgbaston Park Road
Birmingham, England B15 2TY
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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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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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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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Saint Louis, Missouri 63110
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Saint Paul, Minnesota 55114
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Seattle, WA
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