Status:
COMPLETED
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
Lead Sponsor:
Mirum Pharmaceuticals, Inc.
Conditions:
PBC
Primary Biliary Cirrhosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- Diagnosis of Primary Biliary Cirrhosis
- Moderate to severe pruritus
- Taking ursodeoxycholic acid (UDCA) for at least 6 months, or unable to tolerate UDCA
- Ability to understand and willingness to sign informed consent prior to initiation of any study procedures
Exclusion
- History or presence of other concomitant significant liver disease
- Liver transplant
- Known HIV infection
- Women who are pregnant or lactating
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01904058
Start Date
August 1 2013
End Date
April 1 2015
Last Update
March 27 2019
Active Locations (24)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
University of California at Davis
Sacramento, California, United States, 95817
3
University of Miami
Miami, Florida, United States, 33136
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637