RFVIII ( DrugBank: - )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 288 | Autoimmune acquired coagulation factor deficiency | 24 |
288. Autoimmune acquired coagulation factor deficiency
Clinical trials : 205 / Drugs : 238 - (DrugBank : 31) / Drug target genes : 18 - Drug target pathways : 26
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04770935 (ClinicalTrials.gov) | May 3, 2021 | 22/2/2021 | To 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 company | NULL | Recruiting | 18 Years | 65 Years | All | 9 | Phase 1 | United States;France |
| 2 | EUCTR2019-002023-15-IT (EUCTR) | 17/04/2020 | 17/06/2021 | A 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 INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 3 | EUCTR2019-002023-15-DE (EUCTR) | 25/02/2020 | 09/10/2019 | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 4 | EUCTR2019-002023-15-FR (EUCTR) | 06/02/2020 | 04/11/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 5 | EUCTR2019-002023-15-ES (EUCTR) | 28/01/2020 | 02/12/2019 | A 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. | NULL | Authorised-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): no | United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 6 | EUCTR2019-002023-15-BG (EUCTR) | 22/01/2020 | 06/11/2019 | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 7 | EUCTR2019-002023-15-HU (EUCTR) | 21/01/2020 | 20/11/2019 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 8 | EUCTR2019-002023-15-GB (EUCTR) | 06/01/2020 | 10/10/2019 | NA 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 9 | EUCTR2019-002023-15-GR (EUCTR) | 27/12/2019 | 13/11/2019 | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 10 | NCT04161495 (ClinicalTrials.gov) | December 4, 2019 | 5/11/2019 | A 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 A | A 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 | Factor VIII Deficiency | Drug: efanesoctocog alfa (BIVV001) | Bioverativ, a Sanofi company | NULL | Completed | 12 Years | N/A | All | 159 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Spain;Taiwan;United Kingdom |
| 11 | NCT03879135 (ClinicalTrials.gov) | April 1, 2019 | 20/12/2018 | rVWF Pediatric and Adult Study | A 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 Disease | Biological: rVWF;Biological: rFVIII | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | N/A | N/A | All | 64 | Phase 3 | United States;France;Italy;Netherlands;Russian Federation;Spain;Turkey |
| 12 | EUCTR2010-024108-84-BG (EUCTR) | 20/08/2012 | 26/09/2011 | Clinical 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 13 | EUCTR2010-024108-84-ES (EUCTR) | 11/06/2012 | 02/04/2012 | Clinical 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 GmbH | NULL | Not 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): no | United States;Spain;Austria;United Kingdom;Italy;India;France;Canada;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 14 | EUCTR2010-024108-84-NL (EUCTR) | 19/03/2012 | 31/08/2011 | Clinical 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;France;Canada;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 15 | EUCTR2010-024108-84-DE (EUCTR) | 26/01/2012 | 08/08/2011 | Clinical 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 16 | EUCTR2010-024108-84-BE (EUCTR) | 22/12/2011 | 08/09/2011 | Clinical 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 17 | NCT01410227 (ClinicalTrials.gov) | November 1, 2011 | 4/8/2011 | Pharmacokinetics, 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 Disease | Von Willebrand Disease | Biological: Recombinant von Willebrand factor (rVWF);Drug: Placebo;Biological: Recombinant factor VIIII (rFVIII) | Baxalta now part of Shire | NULL | Completed | 18 Years | 65 Years | All | 49 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Germany;India;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;France |
| 18 | EUCTR2010-024108-84-GB (EUCTR) | 31/10/2011 | 05/08/2011 | Clinical 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 19 | EUCTR2010-024108-84-IT (EUCTR) | 25/10/2011 | 01/03/2012 | Clinical 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 GMBH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Italy;United Kingdom;India;Canada;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 20 | EUCTR2010-024108-84-SE (EUCTR) | 10/10/2011 | 12/08/2011 | Clinical 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India | ||
| 21 | EUCTR2010-024108-84-AT (EUCTR) | 06/10/2011 | 23/08/2011 | Clinical 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;India;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 22 | NCT00816660 (ClinicalTrials.gov) | December 1, 2008 | 2/1/2009 | Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease | Recombinant 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 Disease | Biological: Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII);Biological: Marketed plasma-derived VWF/FVIII concentrate | Baxalta now part of Shire | NULL | Completed | 18 Years | 60 Years | All | 32 | Phase 1 | United States;Austria;Canada;Germany;Italy;United Kingdom |
| 23 | EUCTR2019-002023-15-NL (EUCTR) | 25/11/2019 | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands;Japan;Korea, Republic of | |||
| 24 | EUCTR2019-002023-15-BE (EUCTR) | 08/11/2019 | 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 | 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) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of |