63. Idiopathic thrombocytopenic purpura Clinical trials / Disease details


Clinical trials : 363 Drugs : 212 - (DrugBank : 43) / Drug target genes : 47 - Drug target pathways : 138

  
12 trials found
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Status
Inclusion_
agemin
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PhaseCountries
1EUCTR2009-014589-24-FR
(EUCTR)
12/06/201327/09/2011NAProspective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 Primary Immune Thrombocytopenia (ITP)
MedDRA version: 14.0;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: NewGAM
Product Code: NewGAM
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
2EUCTR2012-000796-16-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
3EUCTR2012-000796-16-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
4EUCTR2012-000796-16-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
5EUCTR2012-000796-16-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
6EUCTR2009-014589-24-BG
(EUCTR)
04/01/201213/09/2011NAProspective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 Primary Immune Thrombocytopenia (ITP)
MedDRA version: 16.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NewGAM
Product Code: NewGAM
INN or Proposed INN: Immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India
7EUCTR2011-000263-27-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
8EUCTR2009-014589-24-DE
(EUCTR)
22/09/201112/04/2011NAProspective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.0;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: NewGAM
Product Code: NewGAM
INN or Proposed INN: Immunglobulin
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
9EUCTR2009-014589-24-CZ
(EUCTR)
02/09/201126/04/2011NAProspective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.0;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: NewGAM
Product Code: NewGAM
INN or Proposed INN: immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
10EUCTR2011-000263-27-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
11EUCTR2005-003552-35-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
12EUCTR2005-003552-35-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