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 | EUCTR2018-003297-27-DE (EUCTR) | 15/10/2019 | 28/03/2019 | Therapeutic use of Tadekinig alfa in NLRC4 mutation and XIAP deficiency | Multicenter, double-blind, placebo-controlled, randomized withdrawal trial with Tadekinig alfa (r-hIL-18BP) in patients with IL-18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency | NLRC4 mutationXIAP deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tadekinig alfa Product Code: r-hIL-18BP INN or Proposed INN: Tadekinig alfa Other descriptive name: TADEKINIG ALFA | AB2 Bio Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 3 | United States;Canada;Germany | ||
| 2 | NCT03512314 (ClinicalTrials.gov) | January 24, 2018 | 9/4/2018 | Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency as Open Label Extension | Open-label Extension Study With Tadekinig Alfa (r-hIL-18BP) to Monitor Safety and Tolerability in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP Deficiency | XIAP Deficiency;NLRC4-MAS | Drug: Tadekinig alfa | AB2 Bio Ltd. | NULL | Recruiting | N/A | N/A | All | 10 | Phase 3 | United States;Canada;Germany |
| 3 | NCT03113760 (ClinicalTrials.gov) | July 21, 2017 | 28/2/2017 | Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency | Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial With Tadekinig Alfa (r-hIL-18BP) in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP Deficiency | NLRC4-MAS;XIAP Deficiency | Drug: Tadekinig alfa;Other: 0.9% sodium chloride | AB2 Bio Ltd. | NULL | Recruiting | N/A | N/A | All | 10 | Phase 3 | United States;Canada;Germany |
| 4 | EUCTR2018-003199-10-DE (EUCTR) | 04/10/2018 | OPEN-LABEL STUDY: THERAPEUTIC USE OF TADEKINIG ALFA IN NLRC4 MUTATION AND XIAP DEFICIENCY | Open-label extension study with Tadekinig alfa (r-hIL-18BP) to monitor safety and tolerability in patients with IL-18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency | NLRC4 mutation XIAP deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tadekinig alfa Product Code: r-hIL-18BP INN or Proposed INN: Tadekinig alfa Other descriptive name: TADEKINIG ALFA | AB2 Bio Ltd. | NULL | NA | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Germany |