63. 特発性血小板減少性紫斑病 Idiopathic thrombocytopenic purpura Clinical trials / Disease details


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

  
22 trials found
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1NCT05422365
(ClinicalTrials.gov)
July 26, 202214/6/2022Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in AdultsOpen, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of Bioven, Manufactured by Biopharma Plasma LLC, in Adult Patients With Chronic Primary Immune Thrombocytopenia (ITP)Primary Immune ThrombocytopeniaDrug: Intravenous immunoglobulin (IVIG), 10% solution for infusionBiopharma Plasma LLCNULLRecruiting18 Years65 YearsAll36Phase 3Ukraine
2EUCTR2015-003653-17-CZ
(EUCTR)
07/05/201809/09/2016An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Czech Republic;Spain;Bulgaria;Germany
3EUCTR2015-003653-17-DE
(EUCTR)
27/01/201717/06/2016An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Hungary;Spain;Bulgaria;Germany
4EUCTR2015-003653-17-BG
(EUCTR)
27/01/201721/11/2016An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Hungary;Spain;Bulgaria;Germany
5NCT02859909
(ClinicalTrials.gov)
November 201625/7/2016This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)An Open Label, Prospective, Randomized, Multicenter Study Investigating Clinical Efficacy and Safety of the Human Normal Immunoglobulin for Intravenous Administration BT595 in Patients With Chronic Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaBiological: BT595BiotestSyneos HealthCompleted18 Years75 YearsAll34Phase 3Bulgaria;Czechia;Germany;Hungary;Serbia;Spain
6EUCTR2015-003653-17-HU
(EUCTR)
07/09/201619/07/2016An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Hungary;Spain;Bulgaria;Germany
7EUCTR2015-003653-17-ES
(EUCTR)
06/09/201611/08/2016An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Hungary;Spain;Bulgaria;Germany
8EUCTR2011-001354-29-ES
(EUCTR)
24/09/201219/07/2012An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy
9EUCTR2012-000796-16-PL
(EUCTR)
17/08/201225/06/2012Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopeniaPROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Czech Republic;Poland;Bulgaria
10EUCTR2012-000796-16-BG
(EUCTR)
18/07/201222/05/2012Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopeniaPROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Czech Republic;Poland;Bulgaria
11EUCTR2012-000796-16-DE
(EUCTR)
09/07/201220/03/2012Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopeniaPROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA Primary Immune Thrombocytopenia (ITP)
MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Germany;Czech Republic;Poland;Bulgaria
12EUCTR2012-000796-16-CZ
(EUCTR)
29/05/201204/04/2012Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopeniaPROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Czech Republic;Poland;Bulgaria;Germany
13EUCTR2011-000263-27-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
14EUCTR2011-001354-29-HU
(EUCTR)
09/11/201112/10/2011An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
40France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
15EUCTR2011-001354-29-IT
(EUCTR)
09/11/201107/03/2012An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteriaadopting the new consensus terminology proposed by an internationalworking group (Rodeghiero et al, 2009)
MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: human normal immunoglobulin for intravenous use
Product Code: I10E
INN or Proposed INN: NA
Other descriptive name: NA
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Ukraine;Russian Federation;Germany;Italy
16EUCTR2011-001354-29-DE
(EUCTR)
12/10/201106/10/2011An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
Other descriptive name: human Immunoglobulin
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
40France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
17EUCTR2011-000263-27-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
18EUCTR2008-001597-33-NL
(EUCTR)
18/06/200929/05/2008Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITPDevelopment of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITP Acute Idiopathic Thrombocytopenic Purpura (ITP) in children
MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: Nanogam
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Netherlands
19EUCTR2005-003552-35-DE
(EUCTR)
28/03/200613/01/2006Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/AClinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0;Level: LLT;Classification code 10021245
Product Name: Octagam® 10%
INN or Proposed INN: Human Immunoglobulin G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
116Czech Republic;Germany;France
20EUCTR2005-003552-35-AT
(EUCTR)
20/02/200616/01/2006Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/AClinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0;Level: LLT;Classification code 10021245
Product Name: Octagam® 10%
INN or Proposed INN: Human Immunoglobulin G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
116France;Czech Republic;Austria;Germany
21NCT00151840
(ClinicalTrials.gov)
October 20018/9/2005Efficacy and Safety of IVIG-L in ITP PatientsEfficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)PatientsPurpura, Thrombocytopenic, IdiopathicDrug: IVIG-LSanquinNULLCompleted18 YearsN/ABoth20Phase 3Poland
22EUCTR2011-005586-21-Outside-EU/EEA
(EUCTR)
07/12/2011A research study to determine if an experimental IVIG product, Gammaplex®, is safe, tolerable, and effective when given to patients who have Idiopathic Thrombocytopenic PurpuraA Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura - n/a Idiopathic thrombocytopenic purpura.
MedDRA version: 14.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gammaplex
Product Name: Gammaplex
Product Code: n/a
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Bio Products Laboratory LimitedNULLNAFemale: yes
Male: yes
35Phase 3Argentina;India;United States