KVD900 300 mg Film Coated Tablet ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
65Primary immunodeficiency4

65. Primary immunodeficiency


Clinical trials : 500 Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
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agemax
Inclusion_
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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