Clinical Trials Logo
  1. Home
  2. Primary Biliary Cirrhosis
  3. NCT02321306

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

Primary Biliary Cirrhosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02321306
Study type Interventional
Source Mirum Pharmaceuticals, Inc.
Contact
Status Withdrawn
Phase Phase 2
Start date May 2015
Completion date March 2018
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526665 - Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) Phase 3
Recruiting NCT02931513 - sCD163 in PBC Patients - Assessment of Treatment Response
Active, not recruiting NCT02924701 - sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
Completed NCT02659696 - Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Completed NCT02078882 - Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis Phase 4
Completed NCT01603199 - High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis N/A
Completed NCT01389973 - A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid Phase 2
Completed NCT01857284 - Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis Phase 3
Completed NCT05374200 - Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC) N/A
Recruiting NCT02937012 - Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders Phase 3
Completed NCT02376335 - B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis Phase 2
Recruiting NCT01662973 - Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis Phase 1/Phase 2
Active, not recruiting NCT04751188 - A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis Phase 3
Recruiting NCT04514965 - Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting NCT03668145 - Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis N/A
Completed NCT02955602 - Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) Phase 2
Completed NCT02557360 - Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis Phase 4
Recruiting NCT01440309 - Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis Phase 1
Completed NCT01249092 - Pentoxifylline for Primary Biliary Cirrhosis Phase 2
Completed NCT01510860 - Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis Phase 4