288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 206 / 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
| 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 | EUCTR2018-003453-16-AT (EUCTR) | 23/01/2020 | 21/10/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL,UNCONTROLLED, MULTICENTER STUDY ON LONGTERMSAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VONWILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Germany;Netherlands | ||
| 2 | EUCTR2018-003453-16-IT (EUCTR) | 07/08/2019 | 22/01/2021 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection Product Name: VONICOG Alfa Product Code: [NA] INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection Product Name: VONICOG ALFA Product Code: [na] INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate Product Code: [na] INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate Product Code: [na] INN or Proposed INN: OCTOCOG ALFA | BAXALTA INNOVATIONS GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Germany;Netherlands | ||
| 3 | EUCTR2018-003453-16-FR (EUCTR) | 31/07/2019 | 11/01/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany | ||
| 4 | EUCTR2018-003453-16-DE (EUCTR) | 28/06/2019 | 18/02/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL,UNCONTROLLED, MULTICENTER STUDY ON LONGTERMSAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VONWILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 71 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Germany;Netherlands | ||
| 5 | EUCTR2018-003453-16-ES (EUCTR) | 10/05/2019 | 27/05/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany | ||
| 6 | EUCTR2018-003453-16-NL (EUCTR) | 11/04/2019 | 28/01/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL,UNCONTROLLED, MULTICENTER STUDY ON LONGTERMSAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VONWILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Netherlands;Germany | ||
| 7 | EUCTR2020-003304-13-IE (EUCTR) | 27/10/2022 | A preventive study of bleeding episodes for children with severe von Willebrand disease (VWD). | A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease | severe von Willebrand Disease MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: Vonicog alfa Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: Vonicog alfa Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: Octocog alfa Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: Octocog alfa | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 24 | Phase 3 | France;United States;Canada;Spain;Ireland;Austria;Norway;Netherlands;Italy;Japan;China;Sweden | |||
| 8 | EUCTR2018-003453-16-BE (EUCTR) | 23/06/2022 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL,UNCONTROLLED, MULTICENTER STUDY ON LONGTERMSAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VONWILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | NA | Female: yes Male: yes | 64 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Netherlands;Germany |