Biostate ( 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
1EUCTR2009-017301-11-DE
(EUCTR)
17/11/201113/07/2011This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
26Poland;Ukraine;Bulgaria;Russian Federation;Germany
2NCT01224808
(ClinicalTrials.gov)
October 20108/6/2010Extension Study of Biostate in Subjects With Von Willebrand DiseaseAn 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-08-54Von Willebrand DiseaseBiological: BiostateCSL BehringNULLCompletedN/AN/AAll20Phase 3Bulgaria;Germany;Poland;Russian Federation;Ukraine
3EUCTR2009-017301-11-PL
(EUCTR)
29/09/201018/08/2010This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
26Poland;Ukraine;Bulgaria;Russian Federation;Germany
4EUCTR2009-017301-11-BG
(EUCTR)
20/09/201025/06/2010This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
26Poland;Ukraine;Russian Federation;Bulgaria;Germany
5NCT01213446
(ClinicalTrials.gov)
August 20101/10/2010Study of Biostate® in Children With Von Willebrand DiseaseA Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects With Von Willebrand DiseaseVon Willebrand DiseaseBiological: BiostateCSL BehringParexelCompletedN/A12 YearsAll17Phase 3Belarus;Georgia;Germany;Guatemala;Lebanon;Ukraine;Mexico
6EUCTR2009-017753-34-DE
(EUCTR)
09/07/201015/01/2010This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
12Phase 3Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Germany
7NCT00941616
(ClinicalTrials.gov)
June 200915/7/2009Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand DiseaseAn Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects With Von Willebrand Disease.Von Willebrand DiseaseBiological: Biostate®CSL BehringParexelCompleted12 YearsN/AAll22Phase 2/Phase 3Bulgaria;Poland;Russian Federation;Ukraine;Brazil
8EUCTR2008-004922-18-BG
(EUCTR)
16/04/200913/04/2009An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects with Von Willebrand Disease.An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects with Von Willebrand Disease. Von Willebrand Disease
MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease
MedDRA version: 9.1;Level: PT;Term: Von Willebrand's disease
Product Name: Biostate®
Other descriptive name: von Willebrand Factor
Other descriptive name: Human Coagulation Factor VIII
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
30Bulgaria
9EUCTR2014-005401-20-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
10EUCTR2009-017753-34-BG
(EUCTR)
13/10/2011This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
12Phase 3Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Bulgaria;Germany