Overview
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
Status:
Withdrawn
Withdrawn
Trial end date:
2018-03-01
2018-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mirum Pharmaceuticals, Inc.
Shire
Criteria
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.