288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 205 / 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
| 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-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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 | |||
| 7 | 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 |