65. Primary immunodeficiency Clinical trials / Disease details
Clinical trials : 500 / Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
| 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 | EUCTR2021-001226-21-DE (EUCTR) | 01/12/2022 | 08/03/2022 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 114 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;North Macedonia;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Japan;New Zealand | ||
| 2 | EUCTR2021-001226-21-ES (EUCTR) | 26/05/2022 | 16/03/2022 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 114 | Phase 3 | United States;Greece;Spain;Israel;North Macedonia;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand | ||
| 3 | EUCTR2021-001226-21-HU (EUCTR) | 17/05/2022 | 11/03/2022 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 114 | Phase 3 | United States;Greece;Spain;Israel;North Macedonia;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 4 | NCT05259917 (ClinicalTrials.gov) | February 23, 2022 | 4/2/2022 | A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) | 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 | Hereditary Angioedema | Drug: Placebo;Drug: KVD900 600 mg;Drug: KVD900 300 mg | KalVista Pharmaceuticals, Ltd. | NULL | Recruiting | 12 Years | N/A | All | 114 | Phase 3 | United States;Australia;Bulgaria;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;New Zealand;North Macedonia;Poland;Puerto Rico;Romania;Spain;United Kingdom |
| 5 | EUCTR2021-001226-21-NL (EUCTR) | 28/03/2022 | A 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 Ltd | NULL | NA | Female: yes Male: yes | 114 | Phase 3 | United States;Greece;Spain;Israel;North Macedonia;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand |