65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details


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

  
7 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2018-004489-32-AT
(EUCTR)
02/10/201907/03/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom
2EUCTR2018-004489-32-PL
(EUCTR)
29/08/201929/05/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom
3EUCTR2018-004489-32-IT
(EUCTR)
23/07/201905/01/2021Uno studio per a) valutare la tollerabilità e i livelli ematici di KVD900 quando somministrato come dose singola ai pazienti e b) per valutare se KVD900 è efficace nel trattamento di attacchi di gonfiore nei pazienti con la malattia genetica , angioedema ereditario.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II - KVD900-201 Hereditary Angioedema Type I or II
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: KVD900 100 mg Film Coated Tablet
Product Code: [KVD900 100 mg Film Coated Tablet]
KalVista Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Czechia;Hungary;Poland;Austria;Netherlands;Germany;United Kingdom;Italy
4EUCTR2018-004489-32-DE
(EUCTR)
24/06/201912/02/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Poland;Austria;North Macedonia;Netherlands;Germany;Italy;United Kingdom
5EUCTR2018-004489-32-NL
(EUCTR)
19/06/201925/03/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Poland;Austria;North Macedonia;Germany;Netherlands;Italy;United Kingdom
6EUCTR2018-004489-32-HU
(EUCTR)
21/05/201925/03/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom
7EUCTR2018-004489-32-GB
(EUCTR)
13/03/201927/12/2018A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Macedonia, the former Yugoslav Republic of;Austria;Netherlands;Germany;United Kingdom