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

Status:	Withdrawn
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	3/21/2019
Start Date:	May 2015
End Date:	March 2018

An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Tolerability of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Biliary Cirrhosis

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.

This is an open-label study in subjects with PBC who previously completed the LUM001 201
(CLARITY) study. The study is designed to investigate the long-term safety and tolerability
of LUM001 treatment, with daily dosing for up to 2 years. Changes over time, compared to
baseline, in liver enzymes, other biochemical markers associated with PBC, pruritus, and
other quality of life measures will also be assessed.

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.

We found this trial at

sites

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia 23249

from

Richmond, VA