93. Primary biliary cholangitis Clinical trials / Disease details
Clinical trials : 298 / Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02321306 (ClinicalTrials.gov) | May 2015 | 12/12/2014 | 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With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: LUM001 | Mirum Pharmaceuticals, Inc. | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States;United Kingdom |
| 2 | NCT01904058 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis | A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis | PBC;Primary Biliary Cirrhosis | Drug: LUM001;Drug: Placebo;Drug: Ursodeoxycholic Acid | Mirum Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 66 | Phase 2 | United States;Canada;United Kingdom |
| 3 | EUCTR2013-000482-36-GB (EUCTR) | 08/07/2013 | 13/05/2013 | Phase 2 study to investigate use of LUM001 as a treatment for Primary Biliary Cirrhosis (PBC). This is a chronic and slowly progressive cholestatic liver disease of autoimmune aetiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS. - CLARITY STUDY | Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. Affected individuals are usually in their fifthto seventh decades of life at time of diagnosis, and 90% are women. MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: LUM001 INN or Proposed INN: LUM001 | Lumena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;United Kingdom |