62. 発作性夜間ヘモグロビン尿症 Paroxysmal nocturnal hemoglobinuria Clinical trials / Disease details
臨床試験数 : 271 / 薬物数 : 163 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 106
| 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 | NCT02534909 (ClinicalTrials.gov) | September 9, 2015 | 7/8/2015 | Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria | An Open-label Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316, an Anti-C5 Monoclonal Antibody in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria PNH | Biological: LFG316 | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 2 | Czechia;Japan;Lithuania;Czech Republic;Moldova, Republic of |
| 2 | EUCTR2014-005338-74-LT (EUCTR) | 07/07/2015 | 09/06/2015 | To find out whether LFG316 is able to reduce the destruction of red blood cells in patients with PNH | An open-label proof of concept study to assess the efficacy, safety and pharmacokinetics of LFG316, an anti-C5 monoclonal antibody in patients with paroxysmal nocturnal hemoglobinuria (PNH) - CLFG316X2201 | Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 9 | Phase 2 | Czechia;Czech Republic;Lithuania;Japan | ||
| 3 | EUCTR2014-005338-74-CZ (EUCTR) | 17/06/2015 | 23/04/2015 | To find out whether LFG316 is able to reduce the destruction of red blood cells in patients with PNH | An open-label proof of concept study to assess the efficacy, safety and pharmacokinetics of LFG316, an anti-C5 monoclonal antibody in patients with paroxysmal nocturnal hemoglobinuria (PNH) - CLFG316X2201 | Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 9 | Phase 2 | Czechia;Czech Republic;Lithuania;Japan |