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

  
36 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004675-13-HR
(EUCTR)
28/11/202002/12/2020Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease.CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATEDURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1
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: Wilate 500
Product Name: Wilate
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Trade Name: Wilate 1000
Product Name: Wilate
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Octapharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 3United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
2EUCTR2019-002023-15-IT
(EUCTR)
17/04/202017/06/2021A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients = or >12 Years of Age With Severe Hemophilia A - XTEND-1 severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)]
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR -XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)]
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR -XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)]
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR -
Product Name: Recombinant coagulation FVIII Fc –von Willebrand factor – XTEN fusion protein
Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)]
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTO
BIOVERATIV THERAPEUTICS INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
3EUCTR2019-002023-15-DE
(EUCTR)
25/02/202009/10/2019A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
4EUCTR2019-002023-15-FR
(EUCTR)
06/02/202004/11/2019A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
Bioverativ Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
5EUCTR2019-002023-15-ES
(EUCTR)
28/01/202002/12/2019A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients >=12 Years of Age With Severe Hemophilia A - XTEND-1 Severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Bioverativ Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
164 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
6EUCTR2019-002023-15-BG
(EUCTR)
22/01/202006/11/2019A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
7EUCTR2019-002023-15-HU
(EUCTR)
21/01/202020/11/2019A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
Bioverativ Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
8EUCTR2019-002023-15-GB
(EUCTR)
06/01/202010/10/2019NA Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1).Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 Severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
Bioverativ Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
9EUCTR2019-002023-15-GR
(EUCTR)
27/12/201913/11/2019A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 Severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
10EUCTR2018-004675-13-HU
(EUCTR)
04/06/201905/04/2019Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease. CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1
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: Wilate 500
Product Name: Wilate
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Trade Name: Wilate 1000
Product Name: Wilate
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Octapharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
28 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Czech Republic;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
11EUCTR2018-001631-46-NL
(EUCTR)
14/02/201913/02/2019Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand diseaseImplementation 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
Trade Name: Veyvondi
INN or Proposed INN: VON WILLEBRAND FACTOR
Other descriptive name: VON WILLEBRAND FACTOR
Erasmus University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Netherlands
12EUCTR2013-003305-25-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
13EUCTR2013-003305-25-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
14EUCTR2013-003305-25-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
15EUCTR2013-003305-25-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
16EUCTR2013-003305-25-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
17EUCTR2013-003305-25-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
18EUCTR2006-001383-23-DE
(EUCTR)
19/09/201321/05/2013Efficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedingsEfficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedings - PRO.WILL. Patients with severe, inherited Von Willebrand’s disease and frequent bleedings
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]
Trade Name: FANHDI*INF FL250UI+SIR SOLV+S
Product Name: FANHDI 25 UI
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S
Product Name: FANHDI 50 UI
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S
Product Name: FANHDI 100 UI
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoNULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
19EUCTR2006-001383-23-GB
(EUCTR)
19/04/201213/01/2010Efficacy, 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: Alphanate
Product Name: Alphanate 1000 I.U.
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Trade Name: Alphanate
Product Name: Alphanate 1500 I.U.
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Prof Flora Peyvandi, MDNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Germany;Italy;United Kingdom
20EUCTR2010-023666-46-PL
(EUCTR)
13/12/201120/12/2011A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERYEFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES HAEMOPHILIA A
MedDRA version: 14.1;Level: LLT;Classification code 10018938;Term: Haemophilia A (Factor VIII);System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: FACTANE 200 IU/ml
Product Code: F8VR
Other descriptive name: HUMAN COAGULATION FACTOR VIII
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: no
Male: yes
Poland
21EUCTR2009-017301-11-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
22EUCTR2009-017301-11-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
23EUCTR2009-017301-11-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
24EUCTR2009-017753-34-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
25EUCTR2008-004922-18-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
26EUCTR2005-001426-84-FR
(EUCTR)
14/12/200623/10/2006Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD) - WIL-14Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD) - WIL-14 Wllebrand disease
MedDRA version: 8.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease
Trade Name: WILATE 450
INN or Proposed INN: human coagulation factor VIII
INN or Proposed INN: Factor von Willebrand
Trade Name: WILATE 900
INN or Proposed INN: human coagulation factor VIII
INN or Proposed INN: Factor von Willebrand
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 2France;Czech Republic;Germany
27NCT02250508
(ClinicalTrials.gov)
December 20042/9/2014A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.vonWillebrand's DiseaseBiological: Optivate® (Human Coagulation Factor VIII);Biological: Haemate P® (Human Coagulation Factor VIII)Bio Products LaboratoryNULLCompleted12 YearsN/AAllPhase 2Israel
28NCT02246881
(ClinicalTrials.gov)
October 20012/9/2014A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.Von Willebrand DiseaseBiological: Optivate® (Human Coagulation Factor VIII)Bio Products LaboratoryNULLCompleted12 YearsN/AAllPhase 3Poland;United Kingdom
29EUCTR2019-002023-15-BE
(EUCTR)
08/11/2019Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
30EUCTR2014-005401-20-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
31EUCTR2013-003305-25-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
32EUCTR2018-004675-13-BG
(EUCTR)
27/02/2019Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease.CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATEDURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1
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: Wilate 500
Product Name: Wilate
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Trade Name: Wilate 1000
Product Name: Wilate
INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex
Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 3United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
33EUCTR2009-017753-34-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
34EUCTR2019-002023-15-NL
(EUCTR)
25/11/2019A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1)Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 severe hemophilia A
MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN
Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein
Product Code: BIVV001 (rFVIIIFc-VWF-XTEN)
INN or Proposed INN: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands;Japan;Korea, Republic of
35EUCTR2006-000663-28-PL
(EUCTR)
05/11/2007An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrateAn open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate von Willebrands Disease
MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease
Trade Name: Optivate
Product Code: N/A
INN or Proposed INN: Human coagulation factor VIII associated with von Willebrand factor (VWF)
Bio Products LaboratoryNULLNAFemale: yes
Male: yes
26Phase 3Poland;United Kingdom
36EUCTR2006-000664-85-PL
(EUCTR)
24/10/2007An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing SurgeryAn Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery von Willebrand disease
MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease
Product Code: N/A
INN or Proposed INN: Human coagulation factor VIII associated with Von Willebrand factor (VWF)
Bio Products LaboratoryNULLNAFemale: yes
Male: yes
25Phase 3Poland;United Kingdom