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
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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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University of California-Davis As we begin our second century, UC Davis is poised to become...
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