63. Idiopathic thrombocytopenic purpura Clinical trials / Disease details


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

  
5 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2015-003653-17-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
2EUCTR2015-003653-17-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
3EUCTR2015-003653-17-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): noHungary;Spain;Bulgaria;Germany;Czech Republic
4EUCTR2015-003653-17-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
5EUCTR2015-003653-17-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