288. Autoimmune acquired coagulation factor deficiency
189 clinical trials,   219 drugs   (DrugBank: 29 drugs),   18 drug target genes,   26 drug target pathways

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
65 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04567511
(ClinicalTrials.gov)
March 202129/7/2020Hemlibra in Mild Hemophilia AProspective, Single-Arm, Open-Label Use of Hemlibra (Emicizumab) in the Treatment of Mild Hemophilia AFactor VIII Deficiency, CongenitalDrug: EmicizumabIndiana Hemophilia &Thrombosis Center, Inc.Genentech, Inc.Not yet recruiting5 Years45 YearsMale40Phase 4NULL
2NCT04580407
(ClinicalTrials.gov)
December 15, 20205/10/2020Efficacy and Safety Evaluation of B-Domain Deleted Recombinant Porcine Factor VIII (rpFVIII, TAK-672), in Japanese Participants With Acquired Hemophilia A (AHA)A Phase 2/3, Open-Label, Non-controlled Study to Evaluate the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (rpFVIII, TAK-672), in the Treatment of Serious Bleeding Episode in Japanese Subjects With Acquired Hemophilia A (AHA)Acquired Hemophilia ABiological: TAK-672TakedaNULLNot yet recruiting18 YearsN/AAll5Phase 2;Phase 3Japan
3EUCTR2018-004675-13-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
4EUCTR2019-002023-15-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 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 – vonWillebrand 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 – vonWillebrand 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 – vonWillebrand 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
Bioverativ Therapeutics Inc. (a Sanofi company)NULLAuthorised-recruitment may be ongoing or finishedFemale: 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
5NCT04165135
(ClinicalTrials.gov)
February 24, 202031/10/2019An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care TreatmentA Multicenter, Non-Interventional Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Patients With Haemophilia A Without Inhibitors Receiving Standard of Care TreatmentSevere Hereditary Factor VIII Deficiency Disease Without Inhibitor;Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor;Haemophilia ADrug: Standard of Care for Haemophilia AHoffmann-La RocheNULLRecruiting12 Years50 YearsAll150Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04158648
(ClinicalTrials.gov)
February 10, 20207/11/2019A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII InhibitorsA Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII InhibitorsMild Hereditary Factor VIII Deficiency Disease Without Inhibitor;Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor;Hemophilia ADrug: EmicizumabHoffmann-La RocheNULLRecruitingN/AN/AAll70Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom
7EUCTR2019-002023-15-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
8EUCTR2019-002023-15-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]
Bioverativ Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: 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-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: 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
Bioverativ Therapeutics Inc. (a Sanofi company)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;Korea, Republic of
10EUCTR2019-002023-15-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]
Bioverativ Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-002023-15-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
12EUCTR2019-002023-15-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: 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
Bioverativ Therapeutics Inc. (a Sanofi company)NULLAuthorised-recruitment may be ongoing or finishedFemale: 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
13NCT04161495
(ClinicalTrials.gov)
December 4, 20195/11/2019A 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 AA 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 AFactor VIII DeficiencyDrug: BIVV001Bioverativ, a Sanofi companyNULLRecruiting12 YearsN/AAll150Phase 3United States
14EUCTR2018-001631-46-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
Erasmus University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Netherlands
15EUCTR2013-003305-25-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Greece;Ireland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-003305-25-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
17EUCTR2013-003305-25-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
18EUCTR2013-003305-25-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
19EUCTR2013-003305-25-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
20EUCTR2013-003305-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-003240-23-IE
(EUCTR)
09/12/201310/10/2013To compare the effectiveness of standard weight based dosing of Factor VIII prophylaxis against regimens using an individual's own rate of Factor VIII clearance in adult patients with severe Factor VIII deficiency (Haemophilia A).PERSONALising Factor VIII prophylaxis regimens: Efficacy of standard versus pharmacokinetically based regimens in adult patients with severe Haemophilia A (PERSONAL trial) - PERSONAL trial Severe Haemophilia A
MedDRA version: 14.1;Level: LLT;Classification code 10018937;Term: Haemophilia A;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: ADVATE
INN or Proposed INN: OCTOCOG ALFA
St. James' HospitalNULLNot RecruitingFemale: no
Male: yes
Ireland
22EUCTR2006-001383-23-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
23NCT01968655
(ClinicalTrials.gov)
September 201321/10/2013Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesExpanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesAcquired Hemophilia ABiological: OBI-1Baxalta now part of ShireNULLNo longer available18 YearsN/AAllN/AUnited States
24EUCTR2011-000181-34-DE
(EUCTR)
27/06/201209/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
25EUCTR2006-001383-23-ES
(EUCTR)
24/05/201201/03/2012Efficacy, 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 PoliclinicoNULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-000181-34-IT
(EUCTR)
20/05/201207/08/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Satefy of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies - NA Acquired Haemophilia A
MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
Other descriptive name: recombinant porcine coagulation factor VIII (B domain deleted)
INSPIRATION BIOPHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;United Kingdom;Italy;Sweden;India
27EUCTR2011-000181-34-SE
(EUCTR)
10/05/201207/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;India;Sweden
28EUCTR2011-000181-34-HU
(EUCTR)
04/05/201215/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
29EUCTR2010-021162-30-BG
(EUCTR)
20/12/201107/12/2011This 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 AGNULLNot RecruitingFemale: yes
Male: yes
41Phase 3United States;Turkey;Russian Federation;Bulgaria;Italy;India
30EUCTR2010-023666-46-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2009-017301-11-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
32NCT01410227
(ClinicalTrials.gov)
November 1, 20114/8/2011Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand DiseaseVon Willebrand DiseaseBiological: Recombinant von Willebrand factor (rVWF);Drug: Placebo;Biological: Recombinant factor VIIII (rFVIII)Baxalta now part of ShireNULLCompleted18 Years65 YearsAll49Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Germany;India;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;France
33NCT01800435
(ClinicalTrials.gov)
October 201115/2/2013A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With InhibitorWhole Blood Clot Stability and Thrombin Generating Capacity Following Treatment With Bypassing Agents (BPA) With and Without and Tranexamic Acid (TXA) in Haemophilia A Patients With inhibitor-an In-vivo Prospective Crossover StudyHereditary Factor VIII Deficiency Disease With InhibitorDrug: aPCC, aPCC + TXA;Drug: rFVIIa, rFVIIa + TXAOslo University HospitalNULLCompleted18 Years65 YearsMale6Phase 4Norway
34EUCTR2010-021162-30-IT
(EUCTR)
20/09/201107/03/2012Clinical 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 AGNULLNot RecruitingFemale: yes
Male: yes
41Phase 3United States;Turkey;Bulgaria;Russian Federation;Italy;India
35EUCTR2011-000181-34-GB
(EUCTR)
29/06/201123/06/2011Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Other descriptive name: recombinant porcine coagulation factor VIII (B-domain deleted)
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01178294
(ClinicalTrials.gov)
November 10, 20106/8/2010Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesAcquired Hemophilia ABiological: OBI-1Baxalta now part of ShireNULLCompleted18 YearsN/AAll29Phase 2;Phase 3United States;Canada;India;United Kingdom;France;Germany;Hungary;Italy;Sweden
37EUCTR2009-017301-11-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
38EUCTR2009-017301-11-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
39EUCTR2009-017753-34-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
40EUCTR2009-017060-17-NL
(EUCTR)
10/12/200905/11/2009STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII - STIMULATESTIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII - STIMULATE Type 1 von Willebrand disease and mild hemophilia ATrade Name: simvastatine
Product Name: simvastatin
INN or Proposed INN: SIMVASTATIN
Trade Name: Minrin
Product Name: Desmopressine
INN or Proposed INN: DESMOPRESSIN
Academic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2008-004922-18-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
42NCT00816660
(ClinicalTrials.gov)
December 20082/1/2009Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand DiseaseRecombinant Von Willebrand Factor / Recombinant Factor VIII Complex (rVWF:rFVIII): A Phase 1 Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability in Type 3 Von Willebrand Disease (VWD)Von Willebrand DiseaseBiological: Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII);Biological: Marketed plasma-derived VWF/FVIII concentrateBaxalta now part of ShireNULLCompleted18 Years60 YearsAll32Phase 1United States;Austria;Canada;Germany;Italy;United Kingdom
43EUCTR2008-001910-25-SK
(EUCTR)
17/07/200813/05/2008Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over studyPharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study Inherited von Willebrand Disease (VWD) type 3
MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease
Trade Name: WILATE® 450
INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination
Trade Name: Haemate® P 250
INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Slovakia
44EUCTR2007-004943-31-SE
(EUCTR)
03/10/200712/09/2007The VWD International Prophylaxis (VIP) Study - VIP studyThe VWD International Prophylaxis (VIP) Study - VIP study Severe form of von Willebrand diseaseTrade Name: Haemate-P, Wilate
Product Name: VWD factor VIII concentrate
Product Code: Factor VIII
Centre of Thrombosis and HaemostasisNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Sweden
45EUCTR2005-004435-22-FR
(EUCTR)
01/09/200727/03/2007Incidence of inhibitors in previously untreated patient with severe haemophilia A treated with Octanate (Phase III) - Etude AVI 4-03Incidence of inhibitors in previously untreated patient with severe haemophilia A treated with Octanate (Phase III) - Etude AVI 4-03 Hémophilie A sévère
MedDRA version: 9.1;Level: LLT;Classification code 10018937;Term: Haemophilia A
MedDRA version: 9.1;Classification code 10060612;Term: Hemophilia A
MedDRA version: 9.1;Level: PT;Classification code 10016080;Term: Factor VIII deficiency
MedDRA version: 9.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders
Trade Name: OCTANATE 50 UI/ml, poudre et solvant pour solution injectable
Trade Name: OCTANATE 100 UI/ml, poudre et solvant pour solution injectable
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
35Phase 3Czech Republic;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00404300
(ClinicalTrials.gov)
February 200727/11/2006Optivate in People With Von Willebrand Disease 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 SurgeryVon Willebrand DiseaseDrug: OptivateBio Products LaboratoryNULLTerminated12 YearsN/ABoth25Phase 3Israel;United Kingdom
47EUCTR2006-000664-85-GB
(EUCTR)
19/12/200607/12/2006An 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 - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having 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 - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having Surgery von Willebrand diseaseTrade Name: Optivate
Product Name: Optivate
Product Code: N/A
Bio Products LaboratoryNULLNot RecruitingFemale: yes
Male: yes
25Phase 3Poland;United Kingdom
48EUCTR2005-001426-84-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Czech Republic;Germany;France
49NCT00387192
(ClinicalTrials.gov)
November 200611/10/2006A Study With OPTIVATE® in People With Von Willebrand DiseaseAn 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 ConcentrateVon Willebrand DiseaseDrug: OptivateBio Products LaboratoryNULLTerminated12 YearsN/ABoth26Phase 3Israel;United Kingdom
50EUCTR2006-000663-28-GB
(EUCTR)
28/09/200622/02/2008An 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 - A PK study on Optivate in patients with von Willebrands DiseaseAn 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 - A PK study on Optivate in patients with von Willebrands Disease von Willebrands DiseaseTrade Name: Optivate
Product Name: Optivate
Bio Products LaboratoryNULLNot RecruitingFemale: yes
Male: yes
26Phase 3Poland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2006-001383-23-IT
(EUCTR)
30/06/200628/11/2006Efficacy, 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 - PRO.WILLEfficacy, 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 - PRO.WILL patients with severe inherited VWD unresponsive to DDAVP and with frequent bleedings
MedDRA version: 8.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease
Trade Name: ALPHANATE*INF 1F 1500UI+F 10ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI*INF FL 250UI+SIR SOLV+S
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 250UI+F 5ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 500UI+F 5ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 1000UI+F 10ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S
INN or Proposed INN: Coagulation factor VIII
Trade Name: ALPHANATE*INF 1F 250UI+F 5ML
INN or Proposed INN: Coagulation factor VIII
Trade Name: FANHDI 250UI*1F 250UI+F 10ML
INN or Proposed INN: Coagulation factor VIII
FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMINULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
52EUCTR2005-004496-38-DK
(EUCTR)
22/06/200609/05/2006Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy.Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy. von Willebrand disease (VWD) is an inherited bleeding disorder, characterised mainly by mucosal bleedings, which may be life-threatening, and joint bleeds in severe VWD cases. VWD is caused by a lack of von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Treatment of VWD aims at normalizing the VWF activity in plasma, which can be achieved by stimulating the endogenous release of VWF with desmopressin (DDAVP, 1-desamino-8-D arginine vasopressin) or by infusion of a VWF concentrate.Trade Name: Octostim
Product Name: Octostim
Product Code: DDAVP (Desmopressin)
Trade Name: Octostim
Product Name: Octostim
Product Code: DDAVP (Desmopressin)
Rigshospitalet, CopenhagenNULLNot RecruitingFemale: yes
Male: yes
150Denmark
53NCT00306670
(ClinicalTrials.gov)
April 200623/3/2006Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia AA Prospective, Phase II/III Randomized, Mult-institutional Controlled, Open-label, Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia AHemophilia ADrug: Rituxan;Drug: prednisoneGeorgetown UniversityGenentech, Inc.Terminated18 Years65 YearsAll2Phase 2;Phase 3United States
54EUCTR2004-004868-69-SE
(EUCTR)
25/04/200509/03/2005Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s DiseaseStudy of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease Von Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD.
MedDRA version: 7.1;Level: LLT;Classification code 10047715
Trade Name: Humate-P
Product Name: Humate-P
Other descriptive name: Von Willebrand Factor Ristocetin Cofactor
INN or Proposed INN: Factor VIII concentrate
Other descriptive name: Factor VIII concentrate
Other descriptive name: Von Willebrand Factor Antigen
ZLB Behring LLCNULLNot RecruitingFemale: yes
Male: yes
30Sweden
55EUCTR2004-004868-69-AT
(EUCTR)
07/03/200531/01/2005Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s DiseaseStudy of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease Von Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD.
MedDRA version: 7.1;Level: LLT;Classification code 10047715
Trade Name: Humate-P
Product Name: Humate-P
Other descriptive name: Von Willebrand Factor Ristocetin Cofactor
INN or Proposed INN: Factor VIII concentrate
Other descriptive name: Factor VIII concentrate
Other descriptive name: Von Willebrand Factor Antigen
ZLB Behring LLCNULLNot RecruitingFemale: yes
Male: yes
30Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02250508
(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
57NCT02246881
(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
58NCT00168090
(ClinicalTrials.gov)
October 200112/9/2005Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.Von Willebrand Disease;Blood Coagulation Disorders;Blood Platelet Disorders;Hematologic DiseaseDrug: Blood coagulation Factor VIII and vWF, humanCSL BehringNULLCompletedN/AN/ABoth30Phase 4United States
59EUCTR2006-000664-85-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
60EUCTR2019-002023-15-BE
(EUCTR)
08/11/2019A 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.NULLNAFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2019-002023-15-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: 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
Bioverativ Therapeutics Inc. (a Sanofi company)NULLAuthorised-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;Germany;Netherlands;Japan;Korea, Republic of
62EUCTR2006-000663-28-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
63EUCTR2013-003305-25-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
64EUCTR2014-005401-20-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
65EUCTR2009-017753-34-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