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 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108

  
3 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT02534909
(ClinicalTrials.gov)
September 9, 20157/8/2015Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal HemoglobinuriaAn 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 PNHBiological: LFG316;Drug: LNP023Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll10Phase 2Czechia;Japan;Lithuania;Czech Republic;Moldova, Republic of
2EUCTR2014-005338-74-LT
(EUCTR)
07/07/201509/06/2015To find out whether LFG316 is able to reduce the destruction of red blood cells in patients with PNHAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
9Phase 2Czechia;Czech Republic;Lithuania;Japan
3EUCTR2014-005338-74-CZ
(EUCTR)
17/06/201523/04/2015To find out whether LFG316 is able to reduce the destruction of red blood cells in patients with PNHAn 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
9Phase 2Czechia;Czech Republic;Lithuania;Japan