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 | 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 | Erasmus University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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-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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 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-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 | ||
| 12 | 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 | ||
| 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-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 | ||
| 15 | 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 | ||
| 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 | EUCTR2016-001478-14-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 | ||
| 17 | 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 | ||
| 18 | EUCTR2013-003305-25-GR (EUCTR) | 02/02/2016 | 17/12/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.1;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: Voncento Product Name: Voncento 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: Voncento Product Name: Voncento 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 | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Greece;Ireland;United Kingdom | |||
| 19 | EUCTR2013-003305-25-DE (EUCTR) | 19/11/2015 | 02/06/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | 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;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento 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: Voncento Product Name: Voncento 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 | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany;United Kingdom;Greece;Poland;Ireland;Austria | ||
| 20 | EUCTR2013-003305-25-AT (EUCTR) | 22/09/2015 | 25/06/2015 | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | 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: Voncento Product Name: Voncento 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: Voncento Product Name: Voncento 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 | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 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 |
| 21 | EUCTR2013-003305-25-PT (EUCTR) | 11/09/2015 | 19/08/2015 | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.0;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: Voncento Product Name: Voncento 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: Voncento Product Name: Voncento 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 | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Portugal;Ireland;United Kingdom | |||
| 22 | EUCTR2013-003305-25-IE (EUCTR) | 03/09/2015 | 09/07/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.1;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: Voncento Product Name: Voncento 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: Voncento Product Name: Voncento 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 | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 23 | EUCTR2013-003305-25-GB (EUCTR) | 07/07/2015 | 05/05/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.1;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: Voncento Product Name: Voncento 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: Voncento Product Name: Voncento 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 | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany;United Kingdom;Greece;Poland;Ireland;Austria | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 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 |
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | EUCTR2006-001383-23-ES (EUCTR) | 24/05/2012 | 01/03/2012 | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings. | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings. | Severe, inherited von Willebrand disease (VWD) and frequent bleedings MedDRA version: 14.1;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: Fanhdi 25 UI FVIII-30 UI FVW Product Name: Fanhdi 25 UI Other descriptive name: coagulación factor VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Fanhdi 50 UI FVIII-60 UI FVW Product Name: Fanhdi 50 UI Other descriptive name: coagulación factor VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Fanhdi 100 UI FVIII-120 UI FVW Product Name: Fanhdi 100 UI Other descriptive name: coagulación factor VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 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 |
| 31 | EUCTR2010-021162-30-BG (EUCTR) | 20/12/2011 | 07/12/2011 | This study in an open label study that is conducted in many centers around the world to investigate whether Wilate is safe and works in patients that need surgery and have von Willebrand disease. | Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate®) In Subjects With Inherited Von Willebrand Disease (VWD) Who Undergo Surgical Procedures. | Surgery in Inherited Von Willebrand Disease (VWD) MedDRA version: 14.1;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] | Product Name: WILATE 500 I.U. Product Code: WILATE 500 I.U. Other descriptive name: Human von Willebrand factor (VWF) and coagulation factor VIII (FVIII) Product Name: WILATE 1000 I.U. Product Code: WILATE 1000 I.U. Other descriptive name: Human von Willebrand factor (VWF) and coagulation factor VIII (FVIII) | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Russian Federation;Bulgaria;Italy;India | ||
| 32 | EUCTR2009-017301-11-DE (EUCTR) | 17/11/2011 | 13/07/2011 | This study investigates the effectiveness and safety of Biostate in children, young adults and adults with von Willebrand Disease, a blood clotting disorder. Patients who completed clinical studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 can be enrolled (extension study). | An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects with Von Willebrand Disease who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 | Von Willebrand's Disease MedDRA version: 14.1;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] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Bulgaria;Russian Federation;Germany | |||
| 33 | EUCTR2010-021162-30-IT (EUCTR) | 20/09/2011 | 07/03/2012 | Clinical trial to test if the study drug is safe and if it works well in severe Type 3 von Willebrand patients that need to have a major surgery. | Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate) In Subjects With Inherited Type 3 Von Willebrand Disease (VWD) Who Undergo Major Surgical Procedures. - WIL-24 | Surgery in Inherited Von Willebrand Disease (VWD) MedDRA version: 14.1;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] | Product Name: Wilate 500 I.U. Product Code: Wilate 500 I.U. INN or Proposed INN: NA Other descriptive name: Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII) Product Name: Wilate 1000 I.U. Product Code: Wilate 1000 I.U. INN or Proposed INN: NA Other descriptive name: Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII) | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Bulgaria;Russian Federation;Italy;India | ||
| 34 | EUCTR2009-017301-11-PL (EUCTR) | 29/09/2010 | 18/08/2010 | This study investigates the effectiveness and safety of Biostate in children, young adults and adults with von Willebrand Disease, a blood clotting disorder. Patients who completed clinical studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 can be enrolled (extension study). | An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects with Von Willebrand Disease who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 | Von Willebrand's Disease MedDRA version: 16.0;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] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Bulgaria;Russian Federation;Germany | |||
| 35 | EUCTR2009-017301-11-BG (EUCTR) | 20/09/2010 | 25/06/2010 | This study investigates the effectiveness and safety of Biostate in children, young adults and adults with von Willebrand Disease, a blood clotting disorder. Patients who completed clinical studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 can be enrolled (extension study). | An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects with Von Willebrand Disease who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 | Von Willebrand's Disease MedDRA version: 14.0;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] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Russian Federation;Bulgaria;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 |
| 36 | EUCTR2009-017753-34-DE (EUCTR) | 09/07/2010 | 15/01/2010 | This clinical study investigates the effectiveness and safety of Biostate in children with von Willebrand’s disease (VWD), a blood clotting disorder. A two day investigation of the pharmacokinetics on 0,5, 4 8 12 24 and 48 h after administration (metabolism of Biostate by the child’s body) is a part of the investigation. | A Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects with von Willebrand Disease. | Von Willebrand Disease MedDRA version: 14.1;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] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Germany | ||
| 37 | EUCTR2007-004116-32-BE (EUCTR) | 11/05/2010 | 27/07/2009 | CLINICAL STUDY CONDUCTED WITH WILFACTIN (THAT IS A HUMAN VON WILLEBRAND FACTOR) TO DEMONSTRATE THE EFFICACY AND THE SAFETY OF THE PRODUCT ADMINISTERED BY CONTINUOUS INFUSION IN A SPECIFIC SITUATION: PATIENTS WITH SEVERE VON WILLEBRAND DEFICIENCY UNDERGOING MAJOR SURGERY | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | Severe von Willebrand disease patients undergoing elective major surgery MedDRA version: 13.1;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] | Trade Name: WILFACTIN Product Name: WILFACTIN INN or Proposed INN: Human von Willebrand factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 3 | France;Belgium | ||
| 38 | EUCTR2007-004116-32-FR (EUCTR) | 03/12/2008 | 12/03/2009 | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | Severe von Willebrand disease patients undergoing elective major surgery MedDRA version: 9.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency | Trade Name: WILFACTIN Product Name: WILFACTIN INN or Proposed INN: Human von Willebrand factor | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Belgium;France | |||
| 39 | EUCTR2004-005051-34-BE (EUCTR) | 18/04/2005 | 31/05/2007 | Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE | Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE | Von Willebrand disease Classification code 10047715 | Trade Name: WILFACTIN Product Name: WILFACTIN Product Code: VWF SD-35-DH INN or Proposed INN: human von Willebrand factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 15 | Belgium | |||
| 40 | EUCTR2005-001746-17-BE (EUCTR) | 13/04/2005 | 12/11/2007 | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | von Willebrand disease Classification code 10047715 | Trade Name: WILFACTIN Product Name: WILFACTIN Product Code: VWF SD-35-DH INN or Proposed INN: Human von Willebrand Factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 4 | Belgium | ||
| 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 |
| 41 | NCT00004667 (ClinicalTrials.gov) | October 1993 | 24/2/2000 | Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease | Von Willebrand's Disease | Drug: von Willebrand factor | National Center for Research Resources (NCRR) | University of North Carolina | Completed | N/A | N/A | Both | 10 | Phase 1 | NULL | |
| 42 | EUCTR2005-001746-17-PL (EUCTR) | 20/01/2009 | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | von Willebrand disease MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease | Trade Name: WILFACTIN Product Name: WILFACTIN Product Code: VWF SD-35-DH INN or Proposed INN: Human von Willebrand Factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | Belgium;Poland | |||
| 43 | EUCTR2013-003305-25-PL (EUCTR) | 10/11/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | 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: Voncento Product Name: Voncento 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: Voncento Product Name: Voncento 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 | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | |||
| 44 | EUCTR2009-017753-34-BG (EUCTR) | 13/10/2011 | This clinical study investigates the effectiveness and safety of Biostate in children with von Willebrand's disease (VWD), a blood clotting disorder. A two day investigation of the pharmacokinetics (metabolism of Biostate by the child's body) is a part of the investigation – 0.5, 4, 8, 12, 24 and 48h after administration. | A Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects with von Willebrand Disease. | Von Willebrand Disease MedDRA version: 14.0;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] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Bulgaria;Germany | |||
| 45 | 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 |