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

  
6 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000136-59-BG
(EUCTR)
12/11/202105/10/2021A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II 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: KVD824 300 mg Modified Release Tablets
INN or Proposed INN: To be confirmed
Other descriptive name: KVD824 hydrochloride
Kalvista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Czechia;North Macedonia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand
2EUCTR2021-000136-59-IT
(EUCTR)
21/10/202127/07/2021A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II - N/A 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: KVD824 300 mg Compresse a rilascio modificato
Product Code: [N/A]
Other descriptive name: KVD824 hydrochloride
KalVista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Czechia;North Macedonia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand
3EUCTR2021-000136-59-CZ
(EUCTR)
13/10/202125/08/2021A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II 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: KVD824 300 mg Modified Release Tablets
INN or Proposed INN: To be confirmed
Other descriptive name: KVD824 hydrochloride
Kalvista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Czechia;North Macedonia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand
4NCT05055258
(ClinicalTrials.gov)
September 27, 202114/9/2021A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or IIRandomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of 3 Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or IIAngioedema, Hereditary, Types I and IIDrug: KVD824;Drug: Placebo to KVD824KalVista Pharmaceuticals, Ltd.NULLRecruiting18 YearsN/AAll48Phase 2United States;Australia;Canada;Czechia;France;Germany;Hungary;Italy;New Zealand;Puerto Rico;United Kingdom
5EUCTR2021-000136-59-HU
(EUCTR)
24/09/202116/07/2021A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II 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: KVD824 300 mg Modified Release Tablets
INN or Proposed INN: To be confirmed
Other descriptive name: KVD824 hydrochloride
Kalvista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Czechia;North Macedonia;Italy;United Kingdom;France;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand
6EUCTR2021-000136-59-DE
(EUCTR)
20/09/202122/07/2021A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II 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: KVD824 300 mg Modified Release Tablets
INN or Proposed INN: To be confirmed
Other descriptive name: KVD824 hydrochloride
Kalvista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Czechia;North Macedonia;Italy;United Kingdom;France;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand