65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
| 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 | EUCTR2018-004489-32-AT (EUCTR) | 02/10/2019 | 07/03/2019 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2018-004489-32-PL (EUCTR) | 29/08/2019 | 29/05/2019 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2018-004489-32-IT (EUCTR) | 23/07/2019 | 05/01/2021 | Uno 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Czechia;Hungary;Poland;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-004489-32-DE (EUCTR) | 24/06/2019 | 12/02/2019 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Poland;Austria;North Macedonia;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2018-004489-32-NL (EUCTR) | 19/06/2019 | 25/03/2019 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Poland;Austria;North Macedonia;Germany;Netherlands;Italy;United Kingdom | ||
| 6 | EUCTR2018-004489-32-HU (EUCTR) | 21/05/2019 | 25/03/2019 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2018-004489-32-GB (EUCTR) | 13/03/2019 | 27/12/2018 | A 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 | NULL | Authorised-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): no | United States;Hungary;Macedonia, the former Yugoslav Republic of;Austria;Netherlands;Germany;United Kingdom |