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 | EUCTR2014-003575-38-NL (EUCTR) | 09/04/2015 | 09/12/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant 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 Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor 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 | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Netherlands;Germany | ||
| 2 | EUCTR2014-003575-38-DE (EUCTR) | 25/03/2015 | 22/12/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant 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 Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor 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 | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Germany;Netherlands | ||
| 3 | EUCTR2014-003575-38-IT (EUCTR) | 27/01/2015 | 17/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 17.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant 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 Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Australia;Germany;Netherlands | ||
| 4 | EUCTR2014-003575-38-ES (EUCTR) | 26/01/2015 | 16/12/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 17.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant 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 Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Argentina;Australia;Germany;Netherlands | ||
| 5 | EUCTR2014-003575-38-CZ (EUCTR) | 26/01/2015 | 19/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant 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 Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor 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 | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Australia;Germany;Netherlands | ||
| 6 | EUCTR2014-003575-38-GB (EUCTR) | 15/01/2015 | 26/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant 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 Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor 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 | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Argentina;Australia;Germany;Netherlands | ||
| 7 | EUCTR2014-003575-38-AT (EUCTR) | 07/01/2015 | 10/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant 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 Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor 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 | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Germany;Netherlands |