Ig VENA 50 g/l solution for infusion 100 ml vial + infusion set ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
63特発性血小板減少性紫斑病1
65原発性免疫不全症候群1

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-000961-36-DE
(EUCTR)
15/11/201305/08/2013See the full titleTolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP)
MedDRA version: 16.1;Level: PT;Classification code 10054979;Term: Secondary immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 16.1;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ig VENA 50 g/l solution for infusion 100 ml vial + infusion setKedrion SpANULLNot RecruitingFemale: yes
Male: yes
35Phase 3Germany;Italy

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-000961-36-DE
(EUCTR)
15/11/201305/08/2013See the full titleTolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP)
MedDRA version: 16.1;Level: PT;Classification code 10054979;Term: Secondary immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 16.1;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ig VENA 50 g/l solution for infusion 100 ml vial + infusion setKedrion SpANULLNot RecruitingFemale: yes
Male: yes
35Phase 3Germany;Italy