94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details
臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
| 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 | EUCTR2014-005558-21-GB (EUCTR) | 25/03/2015 | 06/01/2015 | A phase 2a trial to evaluate the safety and tolerability of LUM001 in subjects with Primary Sclerosing Cholangitis (PSC) during 14 weeks of treatment. | A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Primary Sclerosing Cholangitis (PSC) - CAMEO STUDY | Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease of unknown aetiology.PSC is characterized by inflammation and fibrosis of the intra- and extrahepatic biliary tree resulting in diffuse multifocal stricture formation leading to biliary cirrhosis, portal hypertension and liver failure. PSC is a life-threatening and debilitating disease. The median survival from diagnosis in symptomatic patients with PSC has been estimated to be 12 years. MedDRA version: 17.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: LUM001 INN or Proposed INN: LUM001 | Lumena Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;United Kingdom | ||
| 2 | NCT02061540 (ClinicalTrials.gov) | March 2014 | 11/2/2014 | Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis | A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis (PSC) | Drug: LUM001 | Mirum Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 27 | Phase 2 | United States;Canada;United Kingdom |