An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis

Withdrawn before enrolling · Phase 2

Conditions studied: Primary Biliary Cirrhosis

In brief

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.

Key facts

Study ID

NCT02321306

Run by

Mirum Pharmaceuticals, Inc.

People needed

0

Starts

2015-05-01

Expected to finish

2018-03-01

Last updated by the study team

2019-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed a core treatment protocol of LUM001 in the treatment of Primary Biliary Cirrhosis.
• Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures.

You may not qualify if…

• Presence of advanced liver disease.
• History of non-adherence during the subject's participation in the core LUM001 treatment protocol.

Where it is running

• Scripps Clinic — La Jolla, California, United States
• University of California at Davis — Sacramento, California, United States
• University of Miami — Miami, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Minnesota Gastroenterology — Saint Paul, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Liver Institute of Virginia — Newport News, Virginia, United States
• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
• University of Washington Harborview Medical Center — Seattle, Washington, United States
• University of Birmingham — Birmingham, England, United Kingdom
• Royal Liverpool & Broadgreen University Hospital — Liverpool, England, United Kingdom
• Newcastle University — Newcastle upon Tyne, England, United Kingdom
• Oxford University Hospitals (John Radcliffe) — Oxford, England, United Kingdom
• Royal Free Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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