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

NCT ID: NCT02321306

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Biliary Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LUM001

LUM001 administered orally once each day.

Group Type EXPERIMENTAL

LUM001

Intervention Type DRUG

LUM001 administered orally once each day.

Interventions

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LUM001

LUM001 administered orally once each day.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mirum Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Mirum

Locations

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University of Birmingham

Birmingham, England, United Kingdom

Site Status

Scripps Clinic

La Jolla, California, United States

Site Status

University of California at Davis

Sacramento, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Minnesota Gastroenterology

Saint Paul, Minnesota, United States

Site Status

St. Louis University

St Louis, Missouri, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Liver Institute of Virginia

Newport News, Virginia, United States

Site Status

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Site Status

University of Washington Harborview Medical Center

Seattle, Washington, United States

Site Status

Royal Liverpool & Broadgreen University Hospital

Liverpool, England, United Kingdom

Site Status

Newcastle University

Newcastle upon Tyne, England, United Kingdom

Site Status

Oxford University Hospitals (John Radcliffe)

Oxford, England, United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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2014-003433-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LUM001-202

Identifier Type: -

Identifier Source: org_study_id

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