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

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001226-21-DE
(EUCTR)
01/12/202208/03/2022A study to evaluate if different doses of KVD900 are safe and effective in treating attacks in patients with Hereditary Angioedema.A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II - KONFIDENT Hereditary Angioedema Type I or II
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850
MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: KVD900 300 mg Film Coated Tablet
INN or Proposed INN: sebetralstat
Other descriptive name: KVD900
KalVista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
114Phase 3Portugal;United States;Slovakia;Greece;Spain;North Macedonia;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Japan;New Zealand
2EUCTR2021-001226-21-ES
(EUCTR)
26/05/202216/03/2022A study to evaluate if different doses of KVD900 are safe and effective in treating attacks in patients with Hereditary Angioedema.A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II - KONFIDENT Hereditary Angioedema Type I or II
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850
MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: KVD900 300 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
114Phase 3United States;Greece;Spain;Israel;North Macedonia;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand
3EUCTR2021-001226-21-HU
(EUCTR)
17/05/202211/03/2022A study to evaluate if different doses of KVD900 are safe and effective in treating attacks in patients with Hereditary Angioedema.A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II - KONFIDENT Hereditary Angioedema Type I or II
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850
MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: KVD900 300 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
114Phase 3United States;Greece;Spain;Israel;North Macedonia;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;New Zealand
4EUCTR2021-001226-21-NL
(EUCTR)
28/03/2022A study to evaluate if different doses of KVD900 are safe and effective in treating attacks in patients with Hereditary Angioedema.A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II - KONFIDENT Hereditary Angioedema Type I or II
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850
MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: KVD900 300 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals LtdNULLNAFemale: yes
Male: yes
114Phase 3United States;Greece;Spain;Israel;North Macedonia;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand