An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
NCT02321306 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2019-03-19
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.
Conditions
- Primary Biliary Cirrhosis
Interventions
- DRUG
-
LUM001
LUM001 administered orally once each day.
Sponsors & Collaborators
-
Mirum Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Study Director · Mirum
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2017-12-31
- Completion
- 2018-03-31
Countries
- United States
- United Kingdom
Study Locations
More Related Trials
-
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
NCT03742973 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
NCT06750276 ·Status: COMPLETED ·Phase: PHASE2
-
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
NCT03566238 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
NCT02308111 ·Status: TERMINATED ·Phase: PHASE4
-
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
NCT02516605 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
NCT03301506 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men
NCT02138162 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
NCT01899703 ·Status: COMPLETED ·Phase: PHASE2
-
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
NCT02932449 ·Status: COMPLETED
-
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
NCT05104853 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
NCT04950764 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
NCT05014672 ·Status: COMPLETED ·Phase: PHASE2
-
Pasireotide LAR in Severe Polycystic Liver Disease
NCT01670110 ·Status: COMPLETED ·Phase: PHASE2
-
Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
NCT06891365 ·Status: RECRUITING ·Phase: PHASE1
-
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
NCT04933292 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
NCT05050136 ·Status: RECRUITING ·Phase: PHASE2
-
First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases
NCT05599945 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma
NCT01639352 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
NCT00406237 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
NCT04942964 ·Status: COMPLETED ·Phase: PHASE1
-
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
NCT07104201 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
NCT02955602 ·Status: COMPLETED ·Phase: PHASE2
-
Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis
NCT01614405 ·Status: TERMINATED ·Phase: NA
-
A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants
NCT06719128 ·Status: COMPLETED ·Phase: PHASE1
-
Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis
NCT02400216 ·Status: COMPLETED