Human normal immunoglobulin (IVIg)

( DrugBank: - / KEGG DRUG: - )

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
50	皮膚筋炎／多発性筋炎	5

告示番号	疾患名（ページ内リンク）	臨床試験数
65	原発性免疫不全症候群	9

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 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24

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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	EUCTR2021-003302-50-IT (EUCTR)	17/02/2022	26/11/2021	A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodyna ...	A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Eva ...	Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multif ...	Product Name: ARGX-117 IV Product Code: [ARGX-117 IV] Trade Name: Act-HiB Product Name: Haemophilus typ ...	ARGENX BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	48	Phase 2	France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom; ...
2	EUCTR2005-001136-76-IT (EUCTR)	09/07/2007	07/09/2007	Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinatin ...	Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinatin ...	Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Clas ...	Trade Name: IGVENA*FL 200ML 10G+SET INN or Proposed INN: Immunoglobulins, normal human, for intravasc ...	KEDRION	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Italy

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50. 皮膚筋炎／多発性筋炎

臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Countries
1	EUCTR2005-002463-88-HU (EUCTR)	11/03/2010	01/10/2009	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy(Glucoco ...	Trade Name: Ig Vena Product Name: Ig VENA (10g/200mL) Product Code: L0133	Orfagen	NULL	Not Recruiting	Female: yes Male: yes	44	Hungary;Czech Republic;Germany;Italy;Austria
2	EUCTR2005-002463-88-CZ (EUCTR)	16/12/2009	05/10/2009	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy (Glucoc ...	Trade Name: Ig Vena Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human ...	Orfagen	NULL	Not Recruiting	Female: yes Male: yes	44	Hungary;Germany;Czech Republic;Italy;Austria
3	EUCTR2005-002463-88-IT (EUCTR)	17/08/2006	21/04/2006	fficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in t ...	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Idiopathic dermatomyositis and polymyositis with insufficiently improved muscle strength under conve ...	Trade Name: IGVENA*FL 200ML 10G+SET	ORFAGEN	NULL	Not Recruiting	Female: yes Male: yes	44	Czech Republic;Hungary;Austria;Germany;Italy
4	EUCTR2005-002463-88-DE (EUCTR)	18/07/2006	28/12/2005	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucoc ...	Trade Name: Ig VENA Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human ...	Orfagen	NULL	Not Recruiting	Female: yes Male: yes	44	Hungary;Czech Republic;Germany;Italy;Austria
5	EUCTR2005-002463-88-AT (EUCTR)	02/02/2006	17/01/2006	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Efficacy and safety of a human normal immunoglobulinproduct for intravenous administration (IVIg)in ...	Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucoc ...	Trade Name: Ig VENA Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human ...	Orfagen	NULL	Not Recruiting	Female: yes Male: yes	44	Hungary;Czech Republic;Germany;Italy;Austria

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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

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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	EUCTR2020-001496-32-PT (EUCTR)	11/05/2021	11/08/2020	Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ...	A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ...	Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Clas ...	Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin	KEDRION S.P.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 3	Portugal;Hungary;Slovakia;Russian Federation;Italy
2	NCT04944979 (ClinicalTrials.gov)	March 31, 2021	11/6/2021	Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients ...	A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ...	Primary Immunodeficiency Disease	Biological: Kedrion IVIG 10%	Kedrion S.p.A.	NULL	Recruiting	2 Years	16 Years	All	30	Phase 3	Hungary;Italy;Slovakia
3	EUCTR2020-001496-32-IT (EUCTR)	21/12/2020	21/10/2020	Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ...	A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ...	Pediatric Patients Affected by Primary Immunodeficiency Disease MedDRA version: 20.0;Level: PT;Class ...	Product Name: KIg10 Product Code: [KIg10] INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE	KEDRION S.P.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 3	Portugal;Hungary;Slovakia;Italy
4	EUCTR2020-001496-32-SK (EUCTR)	01/10/2020	02/07/2020	Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ...	A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ...	Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Clas ...	Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin	KEDRION S.P.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 3	Portugal;Hungary;Slovakia;Russian Federation;Italy
5	EUCTR2020-001496-32-HU (EUCTR)	09/09/2020	02/07/2020	Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate ...	A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokine ...	Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Clas ...	Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin	KEDRION S.P.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 3	Portugal;Hungary;Slovakia;Russian Federation;Italy
6	EUCTR2010-019249-25-HU (EUCTR)	22/09/2010	06/08/2010	Eine offene, prospektive Studie zur Untersuchung der Pharmakokinetikund Sicherheit (Teil A) des Immu ...	An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal im ...	Primary immunodeficiency disease (PID) MedDRA version: 13.1;Level: LLT;Classification code 10010509; ...	Product Name: Intratect Product Code: BT090 Other descriptive name: Human normal immunoglobulinfor int ...	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	30		Hungary;Germany
7	EUCTR2010-019249-25-DE (EUCTR)	12/08/2010	14/05/2010	An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal im ...	An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal im ...	Primary immunodeficiency disease (PID) MedDRA version: 14.1;Level: LLT;Classification code 10010509; ...	Product Name: Intratect Product Code: BT090 Other descriptive name: Human normal immunoglobulinfor int ...	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	30		Hungary;Germany
8	EUCTR2004-004465-15-HU (EUCTR)	22/07/2005	11/05/2005	A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic ...	A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic ...	primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, commo ...	Trade Name: Intratect Product Name: Intratect Product Code: BT681 Other descriptive name: human normal ...	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	50		Hungary;Germany
9	EUCTR2004-004465-15-DE (EUCTR)	05/04/2005	04/02/2005	A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic ...	A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic ...	primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, commo ...	Product Name: Intratect Product Code: BT681 Other descriptive name: human normal immunoglobulin (IVIg) ...	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	50		Hungary;Germany

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