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Status:	Withdrawn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

University of Birmingham

142 Edgbaston Park Road
Birmingham, England B15 2TY

3180

from 02139

Birmingham,