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 : 205 / 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
| 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 | 64 | 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 | EUCTR2018-001631-46-NL (EUCTR) | 14/02/2019 | 13/02/2019 | Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand disease | Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To WiN | 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: Minrin INN or Proposed INN: DESMOPRESSIN Trade Name: Octostim INN or Proposed INN: DESMOPRESSIN Trade Name: Octostim INN or Proposed INN: DESMOPRESSIN Trade Name: Haemate P INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR INN or Proposed INN: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII Trade Name: Wilate INN or Proposed INN: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Wilfactin INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Veyvondi INN or Proposed INN: VON WILLEBRAND FACTOR Other descriptive name: VON WILLEBRAND FACTOR | Erasmus University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 8 | EUCTR2016-001477-33-BE (EUCTR) | 27/02/2017 | 29/11/2016 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012, P/0214/2015, P/0394/2019 and P/0463/2020 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children 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: VEYONDI 650IU powder and solvent for solution for injection Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: VEYVONDI 1300I IU powder and solvent for solution for injection Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU 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 | 34 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands |