Study Stopped
The study stopped early, before enrolling its first participant.
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
CASCADE
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
2 other identifiers
interventional
N/A
2 countries
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2015
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2014
CompletedFirst Posted
Study publicly available on registry
December 22, 2014
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 19, 2019
March 1, 2019
2.6 years
December 12, 2014
March 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety
Adverse events, serious adverse events, changes in vital signs, laboratory and physical exam findings, and concommitant medication usage from baseline to Week 104
2 years
Secondary Outcomes (5)
Efficacy analysis as changes in liver enzymes and other biochemical markers from baseline to Week 104
2 years
Efficacy analysis as changes in liver enzymes and other biochemical markers from baseline to Week 104
2 years
Efficacy analysis as changes in liver enzymes and other biochemical markers from baseline to Week 104
2 years
Efficacy analysis as changes in liver enzymes and other biochemical markers from baseline to Week 104
2 years
Efficacy analysis as changes in liver enzymes and other biochemical markers from baseline to Week 104
2 years
Study Arms (1)
LUM001
EXPERIMENTALLUM001 administered orally once each day.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Scripps Clinic
La Jolla, California, 92037, United States
University of California at Davis
Sacramento, California, 95817, United States
University of Miami
Miami, Florida, 33136, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Minnesota Gastroenterology
Saint Paul, Minnesota, 55114, United States
St. Louis University
St Louis, Missouri, 63104, United States
Weill Cornell Medical College
New York, New York, 10021, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Liver Institute of Virginia
Newport News, Virginia, 23602, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
University of Washington Harborview Medical Center
Seattle, Washington, 98104, United States
University of Birmingham
Birmingham, England, B15 2TT, United Kingdom
Royal Liverpool & Broadgreen University Hospital
Liverpool, England, L7 8XP, United Kingdom
Newcastle University
Newcastle upon Tyne, England, NE1 4LP, United Kingdom
Oxford University Hospitals (John Radcliffe)
Oxford, England, OX3 9DU, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Mirum
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2014
First Posted
December 22, 2014
Study Start
May 1, 2015
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
March 19, 2019
Record last verified: 2019-03