288. 自己免疫性後天性凝固因子欠乏症［自己免疫性出血病XIII (~2017.3)］
［臨床試験数：189，薬物数：219（DrugBank：29），標的遺伝子数：18，標的パスウェイ数：26］
Searched query = "Autoimmune acquired coagulation factor deficiency", "Coagulation factor deficiency", "Factor XIII deficiency", "Factor VIII deficiency", "Acquired hemophilia A", "von Willebrand Disease", "Factor V deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | EUCTR2016-001477-33-DE (EUCTR) | 12/06/2018 | 27/07/2017 | 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 and P/0214/2015 and P/0394/2019 - 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 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;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 2 | EUCTR2016-001477-33-NL (EUCTR) | 12/04/2018 | 11/01/2018 | 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 and P/0214/2015 - 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] | 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 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;Belgium;Poland;Netherlands;Germany | ||
| 3 | EUCTR2016-001477-33-FR (EUCTR) | 12/03/2018 | 21/02/2017 | 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 and P/0214/2015 - 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] | 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 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 | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 4 | EUCTR2016-001478-14-FR (EUCTR) | 14/02/2018 | 21/03/2017 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 18 | Phase 3 | United States;France;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2016-001478-14-FI (EUCTR) | 14/08/2017 | 03/01/2017 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 22 | Phase 3 | United States;Finland;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Denmark;Germany;Netherlands | ||
| 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 |
| 6 | EUCTR2016-001478-14-DE (EUCTR) | 24/07/2017 | 03/01/2017 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 22 | Phase 3 | United States;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Sweden | ||
| 7 | EUCTR2016-001478-14-NL (EUCTR) | 13/06/2017 | 08/12/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 22 | Phase 3 | United States;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Denmark;Netherlands;Germany | ||
| 8 | EUCTR2016-001477-33-CZ (EUCTR) | 05/04/2017 | 07/12/2016 | 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 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.1;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 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 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 | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 9 | EUCTR2016-001478-14-CZ (EUCTR) | 13/03/2017 | 07/12/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000011919;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 18 | Phase 3 | France;United States;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 10 | 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 and P/0214/2015 - 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: VEYVONDI 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 1300IU 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;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 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 |
| 11 | EUCTR2016-001477-33-GB (EUCTR) | 22/02/2017 | 07/11/2016 | 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 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.0;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 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 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 | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 12 | EUCTR2016-001477-33-ES (EUCTR) | 14/02/2017 | 27/12/2016 | 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 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.0;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 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 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 | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 13 | EUCTR2016-001478-14-ES (EUCTR) | 14/02/2017 | 27/12/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe von Willebrand Disease MedDRA version: 19.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 18 | Phase 3 | France;United States;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 14 | EUCTR2016-001477-33-IT (EUCTR) | 06/02/2017 | 02/11/2016 | 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 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.0;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 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 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 | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 15 | EUCTR2016-001478-14-IT (EUCTR) | 31/01/2017 | 30/11/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe von Willebrand Disease MedDRA version: 19.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 18 | Phase 3 | Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States | ||
| 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 |
| 16 | EUCTR2016-001477-33-AT (EUCTR) | 01/12/2016 | 27/10/2016 | 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 and P/0214/2015 - 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] | 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 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;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 17 | EUCTR2016-001478-14-GB (EUCTR) | 10/11/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe von Willebrand Disease MedDRA version: 19.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 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: 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 | 18 | Phase 3 | United States;France;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden |