288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 205 / 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 2 | NCT04657887 (ClinicalTrials.gov) | November 23, 2015 | 1/12/2020 | Registry of Patients With Von WilLEbrand Disease Treated With Voncento® | Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento® | Von Willebrand Disease | Biological: Voncento® | CSL Behring | NULL | Active, not recruiting | N/A | N/A | All | 135 | France | |
| 3 | 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 | ||
| 4 | NCT02552576 (ClinicalTrials.gov) | October 5, 2015 | 15/9/2015 | 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 | Biological: Voncento | CSL Behring | NULL | Completed | N/A | N/A | All | 26 | Phase 4 | Austria;Germany;Greece;Poland;United Kingdom;Ireland |
| 5 | 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 | ||
| 6 | 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 | |||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | |||
| 10 | EUCTR2014-005401-20-Outside-EU/EEA (EUCTR) | 30/01/2015 | An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD) | An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD) | Von Willebrand's disease (VWD) MedDRA version: 17.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Voncento, Biostate® Product Name: Human coagulation Factor VIII / von Willebrand Factor | CSL Limited | NULL | NA | Female: yes Male: yes | 23 | Australia |