Human Immunoglobulin

( DrugBank: - / KEGG DRUG: - )

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	6

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	23

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

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Showing 1 to 6 of 6 trials

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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	Phase	Countries
1	EUCTR2011-001354-29-ES (EUCTR)	24/09/2012	19/07/2012	An open-label, multicentre efficacy and safety study of a human immunoglobulin(project code I10E) in ...	An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune Thrombo ...	ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminolog ...	Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: H ...	LFB BIOTECHNOLOGIES	NULL	Not Recruiting	Female: yes Male: yes	40	Phase 3	France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy
2	EUCTR2011-001354-29-HU (EUCTR)	09/11/2011	12/10/2011	An open-label, multicentre efficacy and safety study of a human immunoglobulin(project code I10E) in ...	An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune Thrombo ...	ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminolog ...	Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: H ...	LFB BIOTECHNOLOGIES	NULL	Not Recruiting	Female: yes Male: yes	40		France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
3	EUCTR2011-001354-29-DE (EUCTR)	12/10/2011	06/10/2011	An open-label, multicentre efficacy and safety study of a human immunoglobulin(project code I10E) in ...	An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune Thrombo ...	ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminolog ...	Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: H ...	LFB BIOTECHNOLOGIES	NULL	Not Recruiting	Female: yes Male: yes	40		France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
4	EUCTR2005-003552-35-FR (EUCTR)	10/05/2007	29/12/2006	Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic p ...	Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic p ...	the medical condition which have to be investigated is the evolution of platelets counts in adults w ...	Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	116	Phase 3	France;Czech Republic;Austria;Germany
5	EUCTR2005-003552-35-DE (EUCTR)	28/03/2006	13/01/2006	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Pu ...	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Pu ...	Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA ve ...	Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	116		Czech Republic;Germany;France
6	EUCTR2005-003552-35-AT (EUCTR)	20/02/2006	16/01/2006	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Pu ...	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Pu ...	Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA ve ...	Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	116		France;Czech Republic;Austria;Germany

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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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Showing 1 to 10 of 23 trials

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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	EUCTR2020-004734-37-HU (EUCTR)	24/01/2023	17/11/2022	Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Imm ...	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: ...	Product Name: Newnorm INN or Proposed INN: Newnorm Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN ...	Octapharma Pharmazeutika Prod.Ges.m.b.H	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 1;Phase 3	United States;Hungary;Slovakia;Poland;Ukraine;Germany;Netherlands;Italy
2	EUCTR2020-004734-37-DE (EUCTR)	14/12/2021	31/05/2021	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: ...	Product Name: Newnorm INN or Proposed INN: Newnorm Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN ...	Octapharma Pharmazeutika Prod.Ges.m.b.H	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 1;Phase 3	United States;Czechia;Slovakia;Poland;Ukraine;Russian Federation;Germany
3	NCT04640142 (ClinicalTrials.gov)	August 4, 2021	17/11/2020	Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Imm ...	Prospective, Open-label, Single-arm, Multicentre Phase 3 Study to Evaluate the Pharmacokinetics, Eff ...	Primary Immune Deficiency	Biological: Newnorm	Octapharma	NULL	Recruiting	2 Years	75 Years	All	50	Phase 3	United States;Germany;Hungary;Italy;Poland;Slovakia;Ukraine
4	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
5	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
6	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
7	NCT03939533 (ClinicalTrials.gov)	October 17, 2019	3/5/2019	Study to Monitor Subcutaneous Human ImmunoglobulinAdministered at Modified Dosing Regimens in Patien ...	Clinical Phase 3 Study to Monitor the Safety, Tolerability, and Efficacy of Subcutaneous Human Immun ...	Primary Immune Deficiency Disorder	Drug: CUTAQUIG	Octapharma	NULL	Completed	2 Years	75 Years	All	64	Phase 3	United States
8	NCT03988426 (ClinicalTrials.gov)	March 7, 2017	13/6/2019	Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunod ...	Clinical Phase 3 Study to Evaluate the Efficacy, Tolerability and Safety of Subcutaneous Human Immun ...	Primary Immune Deficiency Disorder	Biological: Octanorm	Octapharma	NULL	Completed	18 Years	70 Years	All	25	Phase 3	Russian Federation
9	EUCTR2013-003877-87-SK (EUCTR)	13/01/2017	17/03/2016	Clinical trial to confirm and expand information on absorption, distribution, elimination in the bod ...	CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBC ...	Primary immunodeficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Octanorm 16.5% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: ...	Octapharma Pharmazeutika Prod.Ges.m.b.H	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 1;Phase 3	United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Russian Federation
10	NCT03907241 (ClinicalTrials.gov)	March 1, 2016	7/12/2018	CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMU ...	Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUB ...	Primary Immunodeficiency	Drug: Octanorm 16.5%	Octapharma	NULL	Completed	2 Years	75 Years	All	27	Phase 3	United States;Canada

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