Privigen® ( DrugBank: - )

3 diseases
告示番号疾患名（ページ内リンク）臨床試験数
14慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー2
63特発性血小板減少性紫斑病2
65原発性免疫不全症候群1

14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー

臨床試験数 : 167 /  薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2009-017672-24-FI
(EUCTR)		30/11/201010/09/2010This research study will investigate whether the investigational medicine IgPro10 is efficient and safe for patients with chronic inflammatory demyelinating polyneuropathy (CIDP).A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)		CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes		30Finland
2EUCTR2009-017672-24-BE
(EUCTR)		13/09/201007/07/2010A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 13.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders		Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)		CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes		30Phase 3Finland;Belgium

63. 特発性血小板減少性紫斑病

臨床試験数 : 363 /  薬物数 : 212 - (DrugBank : 43) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 138
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2011-000263-27-BG
(EUCTR)		14/11/201125/08/2011An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP Chronic immune thrombocytopenic purpura (ITP)
MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]		Trade Name: Privigen®
Product Name: Privigen®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN		CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes		150Serbia;Poland;Turkey;Bulgaria
2EUCTR2011-000263-27-PL
(EUCTR)		22/07/201108/06/2011An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP Chronic immune thrombocytopenic purpura (ITP)
MedDRA version: 15.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]		Trade Name: Privigen®
Product Name: Privigen®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN		CSL Behring LLCNULLNot RecruitingFemale: yes
Male: yes		150Serbia;Poland;Turkey;Bulgaria

65. 原発性免疫不全症候群

臨床試験数 : 482 /  薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2014-003772-23-Outside-EU/EEA
(EUCTR)		14/04/2015Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID) Primary Immune Deficiency (Common Variable Immunodeficiency and X-linked agammaglobulinemia)
MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Trade Name: Privigen®
Product Name: Privigen®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN		CSL Behring AGNULLNAFemale: yes
Male: yes		55United States

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