Voncento ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
288自己免疫性後天性凝固因子欠乏症10

288. 自己免疫性後天性凝固因子欠乏症


臨床試験数 : 206 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-003305-25-GR
(EUCTR)
02/02/201617/12/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
2NCT04657887
(ClinicalTrials.gov)
November 23, 20151/12/2020Registry of Patients With Von WilLEbrand Disease Treated With Voncento®Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento®Von Willebrand DiseaseBiological: Voncento®CSL BehringNULLActive, not recruitingN/AN/AAll135France
3EUCTR2013-003305-25-DE
(EUCTR)
19/11/201502/06/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Germany;United Kingdom;Greece;Poland;Ireland;Austria
4NCT02552576
(ClinicalTrials.gov)
October 5, 201515/9/2015Study of Voncento® in Subjects With Von Willebrand DiseaseAn Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects With Von Willebrand DiseaseVon Willebrand DiseaseBiological: VoncentoCSL BehringNULLCompletedN/AN/AAll26Phase 4Austria;Germany;Greece;Poland;United Kingdom;Ireland
5EUCTR2013-003305-25-AT
(EUCTR)
22/09/201525/06/2015An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
6EUCTR2013-003305-25-PT
(EUCTR)
11/09/201519/08/2015An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Portugal;Ireland;United Kingdom
7EUCTR2013-003305-25-IE
(EUCTR)
03/09/201509/07/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
8EUCTR2013-003305-25-GB
(EUCTR)
07/07/201505/05/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Germany;United Kingdom;Greece;Poland;Ireland;Austria
9EUCTR2013-003305-25-PL
(EUCTR)
10/11/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
10EUCTR2014-005401-20-Outside-EU/EEA
(EUCTR)
30/01/2015An 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 LimitedNULLNAFemale: yes
Male: yes
23Australia