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 |
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.
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
University of California-Davis As we begin our second century, UC Davis is poised to become...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Miami A private research university with more than 15,000 students from around the...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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University of Louisville The University of Louisville is a state supported research university located in...
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