RFVIII ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
288Autoimmune acquired coagulation factor deficiency24

288. Autoimmune acquired coagulation factor deficiency


Clinical trials : 205 Drugs : 238 - (DrugBank : 31) / Drug target genes : 18 - Drug target pathways : 26
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT04770935
(ClinicalTrials.gov)
May 3, 202122/2/2021To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)A Phase 1, Open-Label Study to Assess the Pharmacokinetics, and Safety and Tolerability of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Adults With Type 2N and 3 Von Willebrand Disease (VWD)Von Willebrand's Disease (VWD)Drug: efanesoctocog alfa (BIVV001)Bioverativ, a Sanofi companyNULLRecruiting18 Years65 YearsAll9Phase 1United States;France
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
10NCT04161495
(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, Efanesoctocog Alfa (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: efanesoctocog alfa (BIVV001)Bioverativ, a Sanofi companyNULLCompleted12 YearsN/AAll159Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Spain;Taiwan;United Kingdom
11NCT03879135
(ClinicalTrials.gov)
April 1, 201920/12/2018rVWF Pediatric and Adult StudyA Phase 3b, Prospective, Open-label, Uncontrolled, Multicenter Study on Long-term Safety and Efficacy of rVWF in Pediatric and Adult Subjects With Severe Von Willebrand Disease (VWD)Von Willebrand DiseaseBiological: rVWF;Biological: rFVIIIBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruitingN/AN/AAll64Phase 3United States;France;Italy;Netherlands;Russian Federation;Spain;Turkey
12EUCTR2010-024108-84-BG
(EUCTR)
20/08/201226/09/2011Clinical study to explore the influence of the human body on the study drug, on the safety and the efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD Von Willebrand 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
13EUCTR2010-024108-84-ES
(EUCTR)
11/06/201202/04/2012Clinical study to explore the influence of the human body on the study drug, on the safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;United Kingdom;Italy;India;France;Canada;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
14EUCTR2010-024108-84-NL
(EUCTR)
19/03/201231/08/2011Clinical study to explore the influence of the human body on the studydrug, on the safety and the efficacy of recombinant VWF (in combinationwith recombinant FVIII and recombinant VWF alone) in the treatment ofbleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS,SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OFBLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRANDDISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD Von Willebrand 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;France;Canada;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden
15EUCTR2010-024108-84-DE
(EUCTR)
26/01/201208/08/2011Clinical study to explore the influence of the human body on the study drug, on the safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD Von Willebrand 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
16EUCTR2010-024108-84-BE
(EUCTR)
22/12/201108/09/2011Clinical study to explore the influence of the human body on the studydrug, on the safety and the efficacy of recombinant VWF (in combinationwith recombinant FVIII and recombinant VWF alone) in the treatment ofbleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS,SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OFBLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRANDDISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
17NCT01410227
(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
18EUCTR2010-024108-84-GB
(EUCTR)
31/10/201105/08/2011Clinical study to explore the influence of the human body on the study drug, on the safety and the efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD Von Willebrand 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
19EUCTR2010-024108-84-IT
(EUCTR)
25/10/201101/03/2012Clinical study to explore the pharmacokinetics, safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED 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: rVWF
Product Code: BAX111
INN or Proposed INN: Vonicog alfa
Other descriptive name: NA
Trade Name: ADVATE (rAHF-PFM)
INN or Proposed INN: OCTOCOG ALFA
Other descriptive name: NA
BAXTER INNOVATIONS GMBHNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Italy;United Kingdom;India;Canada;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden
20EUCTR2010-024108-84-SE
(EUCTR)
10/10/201112/08/2011Clinical study to explore the influence of the human body on the studydrug, on the safety and the efficacy of recombinant VWF (in combinationwith recombinant FVIII and recombinant VWF alone) in the treatment ofbleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS,SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OFBLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRANDDISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes of VWD 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India
21EUCTR2010-024108-84-AT
(EUCTR)
06/10/201123/08/2011Clinical study to explore the influence of the human body on the study drug, on the safety and the efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD 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: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;United Kingdom;Italy;India;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden
22NCT00816660
(ClinicalTrials.gov)
December 1, 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
23EUCTR2019-002023-15-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
24EUCTR2019-002023-15-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