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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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 with UDCA in combination with LUM001 or placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirum Pharmaceuticals, Inc.; Shire
• Treatments: Ursodeoxycholic Acid

Criteria

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