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

WITHDRAWNPHASE2

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

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

NCT02321306•Mirum Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (18)

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

Key Dates

Start Date

May 1, 2015

Primary Completion Date

December 1, 2017

Completion Date

March 1, 2018

Last Updated

March 19, 2019

Conditions

Primary Biliary Cirrhosis

Interventions

LUM001

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

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