288. 自己免疫性後天性凝固因子欠乏症［自己免疫性出血病XIII (~2017.3)］
［臨床試験数：189，薬物数：219（DrugBank：29），標的遺伝子数：18，標的パスウェイ数：26］
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.
| 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 | NCT04567511 (ClinicalTrials.gov) | March 2021 | 29/7/2020 | Hemlibra in Mild Hemophilia A | Prospective, Single-Arm, Open-Label Use of Hemlibra (Emicizumab) in the Treatment of Mild Hemophilia A | Factor VIII Deficiency, Congenital | Drug: Emicizumab | Indiana Hemophilia &Thrombosis Center, Inc. | Genentech, Inc. | Not yet recruiting | 5 Years | 45 Years | Male | 40 | Phase 4 | NULL |
| 2 | NCT04344860 (ClinicalTrials.gov) | February 1, 2021 | 9/4/2020 | Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial | Prospective, Randomized Trial Comparing Recombinant Von Willebrand Factor (rVWF) Plus Tranexamic Acid vs. rVWF Alone to Reduce Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial | Von Willebrand Diseases;Postpartum Hemorrhage | Drug: Recombinant Von Willebrand factor;Drug: Tranexamic Acid Injection [Cyklokapron] | Margaret Ragni | NULL | Not yet recruiting | 18 Years | N/A | Female | 20 | Phase 3 | United States |
| 3 | NCT04119908 (ClinicalTrials.gov) | January 2021 | 7/10/2019 | Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases | Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases | Von Willebrand Diseases;Glanzmann Thrombasthenia | Device: Sublingual videomicroscopy;Biological: blood sample | University Hospital, Lille | NULL | Not yet recruiting | 18 Years | N/A | All | 400 | N/A | NULL |
| 4 | NCT04580407 (ClinicalTrials.gov) | December 15, 2020 | 5/10/2020 | Efficacy 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 A | Biological: TAK-672 | Takeda | NULL | Not yet recruiting | 18 Years | N/A | All | 5 | Phase 2;Phase 3 | Japan |
| 5 | EUCTR2018-004675-13-HR (EUCTR) | 28/11/2020 | 02/12/2020 | Study 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 3 | United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | ||
| 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 |
| 6 | NCT04052698 (ClinicalTrials.gov) | June 18, 2020 | 9/8/2019 | Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD | Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With Von Willebrand Disease (VWD) | Von Willebrand Diseases | Drug: Wilate | Octapharma | NULL | Recruiting | 6 Years | N/A | All | 28 | Phase 3 | United States;Belarus;Bulgaria;Croatia;Hungary;Lebanon;Russian Federation;Ukraine;Moldova, Republic of |
| 7 | JPRN-JapicCTI-205151 | 15/6/2020 | 07/02/2020 | PHASE III STUDY OF EMICIZUMAB IN PATIENTS WITH ACQUIRED HEMOPHILIA A (AGEHA) | A MULTICENTER, OPEN-LABEL, NON-RANDOMIZED, PHASE III STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB IN PATIENTS WITH ACQUIRED HEMOPHILIA A | Acquired hemophilia A | Intervention name : emicizumab (ACE910, RO5534262) INN of the intervention : emicizumab Dosage And administration of the intervention : Emicizumab will be administered subcutaneously once weekly. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Chugai Pharmaceutical Co., Ltd. | NULL | recruiting | 18 | BOTH | 11 | Phase 3 | Japan | |
| 8 | ChiCTR2000035067 | 2020-05-11 | 2020-07-30 | A multicentre, prospective, single arm study of bortezomib combined with glucocorticoid in the salvage treatment of relapsed / refractory acquired hemophilia A (AHA) | A multicentre, prospective, single arm study of bortezomib combined with glucocorticoid in the salvage treatment of relapsed / refractory acquired hemophilia A (AHA) | Relapsed / refractory acquired hemophilia A (AHA) | Case series:bortezomib combined with glucocorticoid; | Institute of Hematology& Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | NULL | Recruiting | Both | Case series:20; | Phase 4 | China | ||
| 9 | NCT04188639 (ClinicalTrials.gov) | May 2020 | 4/12/2019 | Emicizumab in Acquired Hemophilia A | Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial | Hemophilia A, Acquired | Drug: Emicizumab Injection | GWT-TUD GmbH | Hoffmann-La Roche;Hannover Medical School | Not yet recruiting | 18 Years | N/A | All | 51 | Phase 2 | NULL |
| 10 | 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 | 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) | 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;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 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 |
| 11 | NCT04165135 (ClinicalTrials.gov) | February 24, 2020 | 31/10/2019 | An 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 Treatment | A 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 Treatment | Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor;Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor;Haemophilia A | Drug: Standard of Care for Haemophilia A | Hoffmann-La Roche | NULL | Recruiting | 12 Years | 50 Years | All | 150 | Italy | |
| 12 | NCT04158648 (ClinicalTrials.gov) | February 10, 2020 | 7/11/2019 | A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors | A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII Inhibitors | Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor;Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor;Hemophilia A | Drug: Emicizumab | Hoffmann-La Roche | NULL | Recruiting | N/A | N/A | All | 70 | Phase 3 | United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom |
| 13 | 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 | ||
| 14 | 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] | 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 | |||
| 15 | EUCTR2018-003453-16-AT (EUCTR) | 23/01/2020 | 21/10/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL,UNCONTROLLED, MULTICENTER STUDY ON LONGTERMSAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VONWILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe 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: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Czech Republic;Canada;Belgium;Germany;Netherlands | ||
| 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 |
| 16 | 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: 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) | 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;Korea, Republic of | ||
| 17 | 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] | 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 | |||
| 18 | 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 | ||
| 19 | 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: 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) | 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;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 20 | 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, 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: BIVV001 | Bioverativ, a Sanofi company | NULL | Recruiting | 12 Years | N/A | All | 150 | Phase 3 | United States |
| 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 |
| 21 | NCT04106908 (ClinicalTrials.gov) | November 27, 2019 | 28/8/2019 | Effectiveness and Tolerability of Eqwilate in Real-life Conditions | MOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE Study | VWD - Von Willebrand's Disease | Biological: Eqwilate | Octapharma | NULL | Recruiting | 6 Years | N/A | All | 47 | France | |
| 22 | NCT04146376 (ClinicalTrials.gov) | October 12, 2019 | 29/10/2019 | Von Willebrand Factor in Pregnancy (VIP) Study | Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth | Von Willebrand Diseases | Other: Use of a postpartum diary and additional blood draws;Drug: VWF replacement therapy with Wilate;Drug: Tranexamic acid;Other: Use of a postpartum diary and additional blood draws. | Bloodworks | Mary M. Gooley Hemophilia Center;Ergomed;Octapharma | Recruiting | 18 Years | N/A | Female | 110 | United States | |
| 23 | EUCTR2018-003453-16-FR (EUCTR) | 31/07/2019 | 11/01/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe 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] | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany | |||
| 24 | EUCTR2018-003453-16-DE (EUCTR) | 28/06/2019 | 18/02/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL,UNCONTROLLED, MULTICENTER STUDY ON LONGTERMSAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VONWILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe 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: VEYVONDI 650IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection INN or Proposed INN: VONICOG ALFA Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany | ||
| 25 | NCT04053699 (ClinicalTrials.gov) | June 25, 2019 | 23/7/2019 | Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment | A Prospective, Multicenter, Non-Interventional Study Evaluating the Bleeding Incidence in Patients With Von Willebrand Disease Undergoing On-Demand Treatment | Von Willebrand Diseases | Drug: VWF-containing products | Octapharma | NULL | Active, not recruiting | 66 Months | N/A | All | 35 | United States;Belarus;Bulgaria;Croatia;Hungary;Lebanon;Russian Federation;Ukraine;Moldova, Republic of | |
| 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 |
| 26 | EUCTR2018-004675-13-HU (EUCTR) | 04/06/2019 | 05/04/2019 | Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease. | CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) | Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Octapharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 3 | Belarus;United States;Czech Republic;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | |||
| 27 | EUCTR2018-003453-16-ES (EUCTR) | 10/05/2019 | 27/05/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe 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] | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany | |||
| 28 | EUCTR2018-003453-16-NL (EUCTR) | 11/04/2019 | 28/01/2019 | A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. | A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study | severe 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] | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Netherlands;Germany | |||
| 29 | 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 |
| 30 | EUCTR2018-001631-46-NL (EUCTR) | 14/02/2019 | 13/02/2019 | Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand disease | Implementation 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 Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 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 |
| 31 | NCT03782025 (ClinicalTrials.gov) | February 13, 2019 | 18/12/2018 | Effect of Vitamin K in Critically Ill Patients | Effect of Vitamin K in Critically Ill Patients With Spontaneously Increased Pro-thrombin Time Measured With Routine Coagulation Tests and Advanced Coagulation- and Vitamin K-assays | Coagulation Factor Deficiency;Coagulopathy, Consumption;Vitamin K Deficiency | Drug: Phytomenadione | Region Skane | NULL | Completed | 18 Years | N/A | All | 51 | Sweden | |
| 32 | NCT02606045 (ClinicalTrials.gov) | February 7, 2019 | 5/11/2015 | Minimize Menorrhagia in Women With Von Willebrand Disease | Prospective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Von Willebrand Disease: The VWD Minimize Study | Von Willebrand Diseases | Drug: recombinant von Willebrand factor;Drug: tranexamic acid | Margaret Ragni | University of North Carolina;Duke University | Recruiting | 13 Years | 45 Years | Female | 60 | Phase 3 | United States |
| 33 | NCT03876301 (ClinicalTrials.gov) | January 21, 2019 | 11/3/2019 | Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants | A Multi-Center, Observational Study in Males With Hemophilia A | Blood Coagulation Disorder;Blood Coagulation Disorders, Inherited;Coagulation Protein Disorders;Hemophilia A;Genetic Diseases, Inborn;Genetic Diseases, X-Linked;Hematologic Diseases;Hemorrhagic Disorders;Factor VIII Deficiency | Drug: Standard of Care FVIII Replacement therapy | Spark Therapeutics | NULL | Active, not recruiting | 18 Years | N/A | Male | 55 | United States;Australia;Canada;Thailand | |
| 34 | NCT03700229 (ClinicalTrials.gov) | October 10, 2018 | 4/10/2018 | Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A | An Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A | Acquired Hemophilia A | Drug: Bortezomib;Drug: Rituximab | Peking Union Medical College Hospital | NULL | Unknown status | 18 Years | N/A | All | 22 | Phase 2 | China |
| 35 | NCT03634215 (ClinicalTrials.gov) | August 15, 2018 | 1/7/2018 | Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma | Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma | Multiple Trauma;Coagulation Disorder;Coagulation Factor Deficiency;Coagulation Defect; Acquired | Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity | Masaryk Hospital Krajská zdravotní a.s. | NULL | Unknown status | 18 Years | N/A | All | 200 | NULL | |
| 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 |
| 36 | EUCTR2016-001477-33-DE (EUCTR) | 12/06/2018 | 27/07/2017 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 and P/0394/2019 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children 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: VEYONDI 650IU powder and solvent for solution for injection Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 37 | NCT03613584 (ClinicalTrials.gov) | April 16, 2018 | 22/3/2018 | Von Willebrand Factor Concentrate During ECMO Support | A Double-blind, Placebo-controlled Pilot Trial to Investigate the Administration of Von Willebrand Factor Concentrate (Willfact®, LFB France) in Adult Patients During Extracorporeal Membrane Oxygenation | Acquired Von Willebrand Disease | Drug: Von Willebrand Factor;Drug: Saline Solution | Tirol Kiniken GmbH | LFB BIOMEDICAMENTS | Active, not recruiting | 18 Years | N/A | All | 68 | Phase 2 | Austria |
| 38 | EUCTR2016-001477-33-NL (EUCTR) | 12/04/2018 | 11/01/2018 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children 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] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Phase 3 | United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Netherlands;Germany | ||
| 39 | EUCTR2016-001477-33-FR (EUCTR) | 12/03/2018 | 21/02/2017 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children 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] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 40 | EUCTR2016-001478-14-FR (EUCTR) | 14/02/2018 | 21/03/2017 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 3 | United States;France;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 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 |
| 41 | NCT02973087 (ClinicalTrials.gov) | December 22, 2017 | 22/11/2016 | rVWF IN PROPHYLAXIS | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE | Von Willebrand Disease | Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant) | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Completed | 18 Years | N/A | All | 23 | Phase 3 | United States;Canada;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey |
| 42 | NCT02932618 (ClinicalTrials.gov) | December 18, 2017 | 12/10/2016 | BAX 111 rVWF in Pediatrics | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF With or Without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed With Severe Von Willebrand Disease | Von Willebrand Disease | Biological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant) | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | N/A | 17 Years | All | 34 | Phase 3 | United States;Austria;Belgium;Czechia;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey;Ukraine;United Kingdom |
| 43 | EUCTR2017-003036-37-AT (EUCTR) | 27/10/2017 | 14/09/2017 | The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machine | A double-blind, placebo-controlled pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Von Willebrand factor concentrate during ECMO support | Von Willebrand Disease (VWD) MedDRA version: 20.0;Level: PT;Classification code 10069495;Term: Acquired Von Willebrand's disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Willfact Product Name: Willfact INN or Proposed INN: von Willebrand Faktor Other descriptive name: VON WILLEBRAND FACTOR Trade Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung Product Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung INN or Proposed INN: Natriumchlorid 0,9 % Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% Trade Name: Willfact Product Name: Willfact INN or Proposed INN: von Willebrand Faktor Other descriptive name: VON WILLEBRAND FACTOR Trade Name: Willfact Product Name: Willfact INN or Proposed INN: von Willebrand Faktor Other descriptive name: VON WILLEBRAND FACTOR | Tirol Kliniken GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 68 | Phase 2 | Austria | ||
| 44 | NCT03384277 (ClinicalTrials.gov) | October 26, 2017 | 28/11/2017 | Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab | A Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab | Acquired Hemophilia A | Drug: Steroid;Drug: Rituximab;Drug: Cyclophosphamide | Zhang Lei | Qilu Hospital of Shandong University;Tianjin First Central Hospital;The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital | Recruiting | 18 Years | 80 Years | All | 100 | Phase 3 | China |
| 45 | EUCTR2016-001478-14-FI (EUCTR) | 14/08/2017 | 03/01/2017 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 3 | United States;Finland;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Denmark;Germany;Netherlands | ||
| 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 |
| 46 | EUCTR2016-001478-14-DE (EUCTR) | 24/07/2017 | 03/01/2017 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 3 | United States;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Sweden | ||
| 47 | EUCTR2016-001478-14-NL (EUCTR) | 13/06/2017 | 08/12/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 3 | United States;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Denmark;Netherlands;Germany | ||
| 48 | EUCTR2016-001477-33-CZ (EUCTR) | 05/04/2017 | 07/12/2016 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 49 | EUCTR2016-001478-14-CZ (EUCTR) | 13/03/2017 | 07/12/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000011919;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 3 | France;United States;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 50 | EUCTR2016-000789-53-AT (EUCTR) | 09/03/2017 | 17/10/2016 | The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machine | A pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Willfact during ECMO | Von Willebrand Disease (VWD) MedDRA version: 19.1;Level: PT;Classification code 10069495;Term: Acquired Von Willebrand's disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Willfact Product Name: Willfact INN or Proposed INN: von Willebrand Faktor Other descriptive name: VON WILLEBRAND FACTOR Trade Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung Product Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung INN or Proposed INN: Natriumchlorid 0,9 % Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% Trade Name: Willfact Product Name: Willfact INN or Proposed INN: von Willebrand Faktor Other descriptive name: VON WILLEBRAND FACTOR Trade Name: Willfact Product Name: Willfact INN or Proposed INN: von Willebrand Faktor Other descriptive name: VON WILLEBRAND FACTOR | Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Austria | |||
| 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 |
| 51 | EUCTR2016-001477-33-BE (EUCTR) | 27/02/2017 | 29/11/2016 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children 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: VEYVONDI 650IU powder and solvent for solution for injection Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 52 | EUCTR2016-001477-33-GB (EUCTR) | 22/02/2017 | 07/11/2016 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 53 | EUCTR2016-001478-14-ES (EUCTR) | 14/02/2017 | 27/12/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 3 | France;United States;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 54 | EUCTR2016-001477-33-ES (EUCTR) | 14/02/2017 | 27/12/2016 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 55 | EUCTR2016-001477-33-IT (EUCTR) | 06/02/2017 | 02/11/2016 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 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 |
| 56 | EUCTR2016-001478-14-IT (EUCTR) | 31/01/2017 | 30/11/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 3 | Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States | ||
| 57 | NCT03199794 (ClinicalTrials.gov) | December 14, 2016 | 23/6/2017 | Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice | Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice | Acquired Hemophilia A | Biological: OBIZUR | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | 18 Years | N/A | All | 50 | United States;Austria;France;Germany;Italy;Netherlands;United Kingdom | |
| 58 | EUCTR2016-001477-33-AT (EUCTR) | 01/12/2016 | 27/10/2016 | A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures. | A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012 and P/0214/2015 - BAX 111 rVWF in Pediatrics | Hereditary severe von Willebrand Disease in children 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] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 1000IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Phase 3 | United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands | ||
| 59 | NCT03006965 (ClinicalTrials.gov) | November 11, 2016 | 22/12/2016 | Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT® | Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using an Online Medical Application Based on a Published Population Model and a Bayesian Algorithm | Hemophilia A;Hemophilia;Factor VIII Deficiency | Drug: octocog alfa;Drug: rurioctocog alfa pegol | Spanish Society of Thrombosis and Haemostasis | Takeda;Instituto de Investigación Hospital Universitario La Paz | Recruiting | 1 Year | 65 Years | Male | 100 | Spain | |
| 60 | NCT01651468 (ClinicalTrials.gov) | September 2016 | 25/7/2012 | The Effect of the Nutraceutical Hemofix on the Coagulation System | Phase 1 Study of the Nutraceutical Hemofix Safety and Effect on the Coagulation System | Von Willebrand Disease;Menorrhagia | Dietary Supplement: HEMOFIX | Hadassah Medical Organization | HEMOFIX;Yocheved Grossman;Idan Grossman | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | Israel |
| 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 |
| 61 | EUCTR2013-003305-25-GR (EUCTR) | 02/02/2016 | 17/12/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An 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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Greece;Ireland;United Kingdom | |||
| 62 | NCT02610127 (ClinicalTrials.gov) | December 30, 2015 | 29/10/2015 | Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A | Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A | Acquired Hemophilia A | Biological: OBIZUR | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Completed | 18 Years | N/A | All | 53 | United States | |
| 63 | NCT03871764 (ClinicalTrials.gov) | December 1, 2015 | 8/3/2019 | Prediction of Outcome in Severe Preeclampsia | Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia | Leiden Factor V Deficiency,Preeclampsia;Doppler Examination;Palental Pathology | Diagnostic Test: blood sample , doppler of uterine vessel and placenta | Cairo University | NULL | Completed | N/A | N/A | Female | 100 | NULL | |
| 64 | NCT04657887 (ClinicalTrials.gov) | November 23, 2015 | 1/12/2020 | Registry of Patients With Von WilLEbrand Disease Treated With Voncento® | Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento® | Von Willebrand Disease | Biological: Voncento® | CSL Behring | NULL | Recruiting | N/A | N/A | All | 120 | France | |
| 65 | EUCTR2013-003305-25-DE (EUCTR) | 19/11/2015 | 02/06/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany;United Kingdom;Greece;Poland;Ireland;Austria | ||
| 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 |
| 66 | NCT02552576 (ClinicalTrials.gov) | October 5, 2015 | 15/9/2015 | Study of Voncento® in Subjects With Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects With Von Willebrand Disease | Von Willebrand Disease | Biological: Voncento | CSL Behring | NULL | Completed | N/A | N/A | All | 26 | Phase 4 | Austria;Germany;Greece;Poland;United Kingdom;Ireland |
| 67 | EUCTR2013-003305-25-AT (EUCTR) | 22/09/2015 | 25/06/2015 | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | An 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 68 | EUCTR2013-003305-25-PT (EUCTR) | 11/09/2015 | 19/08/2015 | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | An 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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Portugal;Ireland;United Kingdom | |||
| 69 | EUCTR2013-003305-25-IE (EUCTR) | 03/09/2015 | 09/07/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 70 | EUCTR2013-003305-25-GB (EUCTR) | 07/07/2015 | 05/05/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany;United Kingdom;Greece;Poland;Ireland;Austria | ||
| 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 |
| 71 | EUCTR2014-003575-38-NL (EUCTR) | 09/04/2015 | 09/12/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant human von Willebrand Factor Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Netherlands;Germany | ||
| 72 | NCT02283268 (ClinicalTrials.gov) | April 1, 2015 | 27/10/2014 | Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery | A Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand Disease | Von Willebrand Disease | Biological: Recombinant von Willebrand Factor (rVWF) | Baxalta now part of Shire | NULL | Completed | 18 Years | N/A | All | 24 | Phase 3 | United States;Australia;Austria;Czechia;Germany;Italy;Netherlands;Russian Federation;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic |
| 73 | EUCTR2014-003575-38-DE (EUCTR) | 25/03/2015 | 22/12/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant human von Willebrand Factor Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Germany;Netherlands | ||
| 74 | EUCTR2014-003575-38-IT (EUCTR) | 27/01/2015 | 17/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 17.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant human von Willebrand Factor Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Australia;Germany;Netherlands | ||
| 75 | EUCTR2014-003575-38-ES (EUCTR) | 26/01/2015 | 16/12/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 17.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant human von Willebrand Factor Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Argentina;Australia;Germany;Netherlands | ||
| 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 |
| 76 | EUCTR2014-003575-38-CZ (EUCTR) | 26/01/2015 | 19/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant human von Willebrand Factor Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Australia;Germany;Netherlands | ||
| 77 | EUCTR2014-003575-38-GB (EUCTR) | 15/01/2015 | 26/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Argentina;Australia;Germany;Netherlands | |||
| 78 | EUCTR2014-003575-38-AT (EUCTR) | 07/01/2015 | 10/11/2014 | A study to evaluate the safety and effectiveness of the Recombinant Von Willebrand Factor administred with or without Advate for subjects with severe von Willebrand disease (a hereditary coagulation abnormality) who will undergo major,minor or oral surgery procedures. | A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE - rVWF in subjects with severe VWD undergoing surgery | Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures MedDRA version: 18.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog alfa Other descriptive name: recombinant human von Willebrand Factor Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Product Name: Recombinant von Willebrand Factor Product Code: BAX111 INN or Proposed INN: Vonicog Alfa Other descriptive name: recomibnant human Von Willebrand Factor Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Germany;Netherlands | ||
| 79 | EUCTR2013-003240-23-IE (EUCTR) | 09/12/2013 | 10/10/2013 | To 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' Hospital | NULL | Not Recruiting | Female: no Male: yes | Ireland | ||||
| 80 | NCT02472665 (ClinicalTrials.gov) | December 2013 | 10/6/2015 | Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease | Evaluation of the Pharmacokinetic Profile, Clinical Efficacy and Safety of the Von Willebrand Factor Contained in FANHDI® (Double-inactivated Human Anti-hemophilic Factor) in Pediatric Subjects With Severe Von Willebrand Disease | Von Willebrand Disease | Drug: plasma-derived FVIII/VWF concentrate | Grifols Therapeutics LLC | Instituto Grifols, S.A. | Recruiting | 2 Months | 6 Years | All | 8 | Phase 4 | Spain |
| 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 |
| 81 | EUCTR2012-003450-92-ES (EUCTR) | 23/11/2013 | 29/11/2012 | Evaluation of the dynamic behavior, efficacy and safety of Fanhdi®, a high-purity von Willebrand containing FVIII concentrate, in pediatric patients with von Willebrand disease. | EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WITH VON WILLEBRAND DISEASE - Study of Fanhdi® in pediatric patients with VWD | Severe von Willebrand disease including types I, II, and III with VWF:RCof <15-20% MedDRA version: 14.1;Level: PT;Classification code 10068986;Term: Von Willebrand's factor activity decreased;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Fanhdi | Instituto Grifols S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Spain | |||
| 82 | EUCTR2006-001383-23-DE (EUCTR) | 19/09/2013 | 21/05/2013 | Efficacy, 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 | Efficacy, 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 Policlinico | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 83 | NCT01968655 (ClinicalTrials.gov) | September 2013 | 21/10/2013 | Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Hemophilia A | Biological: OBI-1 | Baxalta now part of Shire | NULL | No longer available | 18 Years | N/A | All | N/A | United States | |
| 84 | 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 | ||
| 85 | EUCTR2011-000181-34-DE (EUCTR) | 27/06/2012 | 09/02/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India | |||
| 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 |
| 86 | 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] | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;India;France;Canada;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden | |||
| 87 | EUCTR2006-001383-23-ES (EUCTR) | 24/05/2012 | 01/03/2012 | 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. | 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 Policlinico | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 88 | EUCTR2011-000181-34-IT (EUCTR) | 20/05/2012 | 07/08/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy 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 BIOPHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;United Kingdom;Italy;Sweden;India | |||
| 89 | EUCTR2011-000181-34-SE (EUCTR) | 10/05/2012 | 07/02/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;India;Sweden | |||
| 90 | EUCTR2011-000181-34-HU (EUCTR) | 04/05/2012 | 15/02/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India | |||
| 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 |
| 91 | EUCTR2006-001383-23-GB (EUCTR) | 19/04/2012 | 13/01/2010 | 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. | 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] | Prof Flora Peyvandi, MD | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;Italy;United Kingdom | |||
| 92 | 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 | ||
| 93 | 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 | ||
| 94 | 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 | ||
| 95 | EUCTR2010-021162-30-BG (EUCTR) | 20/12/2011 | 07/12/2011 | This 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Russian Federation;Bulgaria;Italy;India | ||
| 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 |
| 96 | EUCTR2010-023666-46-PL (EUCTR) | 13/12/2011 | 20/12/2011 | A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERY | EFFICACY 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 BIOTECHNOLOGIES | NULL | Not Recruiting | Female: no Male: yes | Poland | ||||
| 97 | EUCTR2009-017301-11-DE (EUCTR) | 17/11/2011 | 13/07/2011 | This 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Bulgaria;Russian Federation;Germany | |||
| 98 | 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 |
| 99 | 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 | ||
| 100 | 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 | ||
| 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 |
| 101 | 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 | ||
| 102 | 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 | ||
| 103 | NCT01800435 (ClinicalTrials.gov) | October 2011 | 15/2/2013 | A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor | Whole 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 Study | Hereditary Factor VIII Deficiency Disease With Inhibitor | Drug: aPCC, aPCC + TXA;Drug: rFVIIa, rFVIIa + TXA | Oslo University Hospital | NULL | Completed | 18 Years | 65 Years | Male | 6 | Phase 4 | Norway |
| 104 | EUCTR2010-021162-30-IT (EUCTR) | 20/09/2011 | 07/03/2012 | Clinical 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Bulgaria;Russian Federation;Italy;India | ||
| 105 | EUCTR2011-000181-34-GB (EUCTR) | 29/06/2011 | 23/06/2011 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India | |||
| 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 |
| 106 | NCT01365546 (ClinicalTrials.gov) | June 2011 | 27/5/2011 | Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery | Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures | Prevent Bleeding in Major Surgery | Biological: human VWF/FVIII concentrate | Octapharma | NULL | Completed | 6 Years | N/A | All | 30 | Phase 3 | United States;Bulgaria;India;Italy;Oman;Poland;Romania;South Africa;Turkey |
| 107 | NCT01178294 (ClinicalTrials.gov) | November 10, 2010 | 6/8/2010 | Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A | Efficacy 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 Hemophilia A | Biological: OBI-1 | Baxalta now part of Shire | NULL | Completed | 18 Years | N/A | All | 29 | Phase 2;Phase 3 | United States;Canada;India;United Kingdom;France;Germany;Hungary;Italy;Sweden |
| 108 | NCT01224808 (ClinicalTrials.gov) | October 2010 | 8/6/2010 | Extension Study of Biostate in Subjects With Von Willebrand Disease | 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 Disease | Biological: Biostate | CSL Behring | NULL | Completed | N/A | N/A | All | 20 | Phase 3 | Bulgaria;Germany;Poland;Russian Federation;Ukraine |
| 109 | EUCTR2009-017301-11-PL (EUCTR) | 29/09/2010 | 18/08/2010 | This 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Bulgaria;Russian Federation;Germany | |||
| 110 | EUCTR2009-017301-11-BG (EUCTR) | 20/09/2010 | 25/06/2010 | This 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Russian Federation;Bulgaria;Germany | |||
| 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 |
| 111 | EUCTR2009-016869-28-GB (EUCTR) | 20/09/2010 | 07/07/2010 | A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency | A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency | Congenital FXIII A-subunit Deficiency MedDRA version: 13.1;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 3 | United Kingdom | |||
| 112 | EUCTR2010-020192-23-GB (EUCTR) | 20/09/2010 | 06/08/2010 | A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Paediatric Subjects with Congenital Factor XIII A-subunit Deficiency Safety Extension Trial to F13CD-3760 | A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Paediatric Subjects with Congenital Factor XIII A-subunit Deficiency Safety Extension Trial to F13CD-3760 | Congenital Factor XIII A-subunit Deficiency MedDRA version: 17.0;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Recombinant factor XIII (rFXIII) Product Code: NN1841 INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | France;Finland;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 113 | NCT01213446 (ClinicalTrials.gov) | August 2010 | 1/10/2010 | Study of Biostate® in Children With Von Willebrand Disease | 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 | Biological: Biostate | CSL Behring | Parexel | Completed | N/A | 12 Years | All | 17 | Phase 3 | Belarus;Georgia;Germany;Guatemala;Lebanon;Ukraine;Mexico |
| 114 | EUCTR2009-017753-34-DE (EUCTR) | 09/07/2010 | 15/01/2010 | This 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Germany | ||
| 115 | EUCTR2007-004116-32-BE (EUCTR) | 11/05/2010 | 27/07/2009 | CLINICAL STUDY CONDUCTED WITH WILFACTIN (THAT IS A HUMAN VON WILLEBRAND FACTOR) TO DEMONSTRATE THE EFFICACY AND THE SAFETY OF THE PRODUCT ADMINISTERED BY CONTINUOUS INFUSION IN A SPECIFIC SITUATION: PATIENTS WITH SEVERE VON WILLEBRAND DEFICIENCY UNDERGOING MAJOR SURGERY | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | Severe von Willebrand disease patients undergoing elective major surgery MedDRA version: 13.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: WILFACTIN Product Name: WILFACTIN INN or Proposed INN: Human von Willebrand factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 3 | France;Belgium | ||
| 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 |
| 116 | EUCTR2008-007883-41-AT (EUCTR) | 15/03/2010 | 25/01/2010 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 117 | NCT00994929 (ClinicalTrials.gov) | January 2010 | 12/10/2009 | Efficacy and Safety of IL-11 in DDAVP Unresponsive | Phase II Biologic Effects Study of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Moderate or Mild Hemophilia A, or Von Willebrand Disease Unable to Use DDAVP | Hemophilia A;Von Willebrand Disease | Biological: Neumega (Oprelvekin, Interleukin 11, IL-11) | University of Pittsburgh | NULL | Completed | 18 Years | N/A | All | 9 | Phase 2 | United States |
| 118 | EUCTR2009-017060-17-NL (EUCTR) | 10/12/2009 | 05/11/2009 | STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII - STIMULATE | STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII - STIMULATE | Type 1 von Willebrand disease and mild hemophilia A | Trade Name: simvastatine Product Name: simvastatin INN or Proposed INN: SIMVASTATIN Trade Name: Minrin Product Name: Desmopressine INN or Proposed INN: DESMOPRESSIN | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | Netherlands | ||||
| 119 | EUCTR2008-007883-41-IT (EUCTR) | 27/11/2009 | 31/12/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-3720 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-3720 | Factor XIII Congenital deficiency. MedDRA version: 9.1;Level: HLGT;Classification code 10064477 MedDRA version: 9.1;Level: HLT;Classification code 10009737 MedDRA version: 9.1;Level: PT;Classification code 10016083 | Product Name: Recombinant Factor XIII INN or Proposed INN: Coagulation factor XIII | NOVO NORDISK | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;United Kingdom;Italy | |||
| 120 | EUCTR2008-007883-41-ES (EUCTR) | 16/11/2009 | 05/10/2009 | Ensayo multicéntrico, abierto, con un único brazo de tratamiento y dosis múltiples sobre la seguridad de la terapia sustitutiva mensual con factor XIII recombinante (rFXIII) en sujetos con deficiencia congénita de factor XIIIA Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Ensayo multicéntrico, abierto, con un único brazo de tratamiento y dosis múltiples sobre la seguridad de la terapia sustitutiva mensual con factor XIII recombinante (rFXIII) en sujetos con deficiencia congénita de factor XIIIA Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Congenital Factor XIII DeficiencyDeficiencia congénita de factor XIII. MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 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 |
| 121 | EUCTR2008-007883-41-GB (EUCTR) | 04/11/2009 | 23/07/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - Mentor™2 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - Mentor™2 | Congenital Factor XIII Deficiency MedDRA version: 14.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: PT;Classification code 10061992;Term: Haemophilia;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 122 | EUCTR2009-010722-19-ES (EUCTR) | 04/11/2009 | 11/08/2009 | A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII DeficiencyEstudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII DeficiencyEstudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | Congenital Factor XIII deficiencyDeficiencia congénita de factor XIII MedDRA version: 9.1;Level: LLT;Classification code 10016083;Term: Factor XIII deficiency | Trade Name: Fibrogammin® P Product Name: Factor XIII Concentrate (Human), Pasteurized INN or Proposed INN: Factor XIII Concentrate (Human), Pasteurized | CSL Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3b | Spain | ||
| 123 | NCT00978380 (ClinicalTrials.gov) | September 21, 2009 | 15/9/2009 | Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | NULL | Completed | 6 Years | N/A | All | 63 | Phase 3 | United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Japan;Spain;Switzerland;United Kingdom |
| 124 | NCT00945906 (ClinicalTrials.gov) | September 2009 | 23/7/2009 | An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) (FXIII) | CSL Behring | NULL | Completed | N/A | N/A | All | 61 | Phase 3 | United States |
| 125 | EUCTR2008-007883-41-FR (EUCTR) | 13/08/2009 | 05/08/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Finland;United Kingdom;Germany;France;Spain;Italy;Austria | |||
| 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 |
| 126 | EUCTR2008-007883-41-FI (EUCTR) | 13/08/2009 | 15/06/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - Mentor™2 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - Mentor™2 | Congenital Factor XIII Deficiency MedDRA version: 14.1;Level: PT;Classification code 10061992;Term: Haemophilia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 127 | EUCTR2008-007883-41-DE (EUCTR) | 04/08/2009 | 22/06/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency - Mentor™2 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency - Mentor™2 | Congenital Factor XIII Deficiency MedDRA version: 14.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors;Level: PT;Classification code 10061992;Term: Haemophilia;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 128 | NCT00885742 (ClinicalTrials.gov) | August 2009 | 21/4/2009 | A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) | CSL Behring | NULL | Completed | N/A | N/A | All | 41 | Phase 3 | United States;Spain |
| 129 | EUCTR2009-010387-41-ES (EUCTR) | 25/06/2009 | 16/04/2009 | A 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII DeficiencyEstudio de 12 semanas, multicéntrico, de farmacocinética y seguridad del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | A 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII DeficiencyEstudio de 12 semanas, multicéntrico, de farmacocinética y seguridad del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | Congenital Factor XIII deficiencyDeficiencia congénita de factor XIII MedDRA version: 9.1;Level: LLT;Classification code 10016083;Term: Factor XIII deficiency | Trade Name: Fibrogammin®P Product Name: Factor XIII Concentrate (Human), Pasteurized INN or Proposed INN: Factor XIII Concentrate (Human), Pasteurized | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Spain | |||
| 130 | NCT01994330 (ClinicalTrials.gov) | June 2009 | 14/11/2013 | Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery | Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery | Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis;Heye´s Syndrome;Severe Aortic Stenosis | Drug: desmopressin | Pontificia Universidad Catolica de Chile | Ferring Pharmaceuticals | Completed | N/A | N/A | All | 13 | Phase 4 | Chile |
| 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 |
| 131 | NCT00941616 (ClinicalTrials.gov) | June 2009 | 15/7/2009 | Study of a pd VWF/FVIII Concentrate, 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 | Biological: Biostate® | CSL Behring | Parexel | Completed | 12 Years | N/A | All | 22 | Phase 2;Phase 3 | Bulgaria;Poland;Russian Federation;Ukraine;Brazil |
| 132 | NCT00883090 (ClinicalTrials.gov) | May 2009 | 16/4/2009 | A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency | A 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) | CSL Behring | NULL | Completed | N/A | N/A | All | 15 | Phase 2 | United States;Spain |
| 133 | EUCTR2008-004922-18-BG (EUCTR) | 16/04/2009 | 13/04/2009 | An 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Bulgaria | |||
| 134 | EUCTR2008-008532-82-AT (EUCTR) | 19/02/2009 | 21/01/2009 | A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2B | A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2B | von Willebrand Disease type 2B | Product Name: ARC1779 Product Code: ARC1779 | Medical University of Vienna, Dept. of Clinical Pharmacology | NULL | Not Recruiting | Female: yes Male: yes | Austria | ||||
| 135 | EUCTR2007-004116-32-FR (EUCTR) | 03/12/2008 | 12/03/2009 | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA | Severe von Willebrand disease patients undergoing elective major surgery MedDRA version: 9.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency | Trade Name: WILFACTIN Product Name: WILFACTIN INN or Proposed INN: Human von Willebrand factor | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Belgium;France | |||
| 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 |
| 136 | NCT00816660 (ClinicalTrials.gov) | December 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 |
| 137 | EUCTR2008-000795-24-SE (EUCTR) | 06/10/2008 | 15/08/2008 | Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOME | Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOME | von Willebrand disease | Trade Name: Wilate | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Sweden | ||
| 138 | NCT00694785 (ClinicalTrials.gov) | October 2008 | 6/6/2008 | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B | Von Willebrand Disease | Drug: ARC1779 | Archemix Corp. | NULL | Withdrawn | 16 Years | 75 Years | Both | 2 | Phase 2 | NULL |
| 139 | EUCTR2006-003148-51-GB (EUCTR) | 15/08/2008 | 09/05/2008 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 3 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 140 | EUCTR2006-003148-51-FI (EUCTR) | 15/08/2008 | 24/06/2008 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Finland;Germany;United Kingdom;France;Spain;Italy;Austria | |||
| 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 |
| 141 | NCT00713648 (ClinicalTrials.gov) | August 2008 | 7/7/2008 | Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | NULL | Completed | 6 Years | N/A | All | 41 | Phase 3 | United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Spain;Switzerland;United Kingdom |
| 142 | EUCTR2006-003148-51-DE (EUCTR) | 29/07/2008 | 12/06/2008 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 143 | EUCTR2006-003148-51-FR (EUCTR) | 22/07/2008 | 22/05/2008 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Finland;Germany;United Kingdom;France;Spain;Italy;Austria | |||
| 144 | EUCTR2006-003148-51-AT (EUCTR) | 17/07/2008 | 16/06/2008 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Finland;Germany;United Kingdom;France;Spain;Italy;Austria | |||
| 145 | EUCTR2008-001910-25-SK (EUCTR) | 17/07/2008 | 13/05/2008 | Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study | Pharmacokinetics 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Slovakia | ||
| 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 |
| 146 | EUCTR2006-003148-51-IT (EUCTR) | 10/07/2008 | 23/09/2008 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-1725 | Congenital Factor XIII Deficency MedDRA version: 14.1;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10061992;Term: Haemophilia;Level: HLT;Classification code 10009737;Term: Coagulation factor deficiencies;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant Factor XIII Product Code: F13CD INN or Proposed INN: Coagulation factor XIII | NOVO NORDISK | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;United Kingdom;Italy | |||
| 147 | NCT00524225 (ClinicalTrials.gov) | February 2008 | 31/8/2007 | IL-11 in Adults With Von Willebrand Disease Undergoing Surgery | Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery | Von Willebrand Disease | Drug: Neumega (Oprelvekin, Interleukin 11, IL-11) | Margaret Ragni | University of North Carolina;Wyeth is now a wholly owned subsidiary of Pfizer | Terminated | 18 Years | N/A | All | 3 | Phase 2 | United States |
| 148 | NCT00632242 (ClinicalTrials.gov) | January 2008 | 3/3/2008 | ARC1779 Injection in Patients With Von Willebrand Factor-Related Platelet Function Disorders | A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients With Von Willebrand Factor-Related Platelet Function Disorders | Purpura, Thrombotic Thrombocytopenic;Von Willebrand Disease Type-2b | Drug: ARC1779 | Archemix Corp. | NULL | Completed | 18 Years | 75 Years | Both | 28 | Phase 2 | Austria |
| 149 | NCT00524342 (ClinicalTrials.gov) | January 2008 | 31/8/2007 | IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia | Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory Menorrhagia | Von Willebrand Disease | Drug: Oprelvekin, Interleukin 11, IL-11 | Margaret Ragni | University of North Carolina;Wyeth is now a wholly owned subsidiary of Pfizer | Completed | 18 Years | 45 Years | Female | 7 | Phase 2 | United States |
| 150 | EUCTR2005-001426-84-CZ (EUCTR) | 06/12/2007 | 16/10/2007 | CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE | CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE | Inherited von Willebrand Disease MedDRA version: 8.0;Level: PT;Classification code 10047715 | Product Name: Wilate | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany;Czech Republic;France | |||
| 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 |
| 151 | EUCTR2007-004371-19-AT (EUCTR) | 20/11/2007 | 12/12/2007 | A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function Disorders | A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function Disorders | von Willebrand Factor- related platelet function disorders : thrombotic thrombocytopenic purpura(TTP) in remission, acute TTP, and von Willebrand Disease Type- 2b (vWD-2b). MedDRA version: 9.1;Level: LLT;Classification code 10037563;Term: Purpura thrombopenic thrombotic MedDRA version: 9.1;Classification code 10047715;Term: Von Willebrand's disease | Product Name: ARC1779 Injection Product Code: ARC1779 Other descriptive name: ARC 1779 Trade Name: Octostim Product Name: desmopressin acetate Product Code: desmopressin acetate INN or Proposed INN: desmopressin acetate Trade Name: Minirin Product Name: desmopressin Product Code: desmopressin INN or Proposed INN: desmopressin acetate Product Name: ARC1779 Injection Product Code: ARC1779 Other descriptive name: ARC 1779 | Archemix Corp. | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Austria | ||
| 152 | EUCTR2007-004943-31-SE (EUCTR) | 03/10/2007 | 12/09/2007 | The VWD International Prophylaxis (VIP) Study - VIP study | The VWD International Prophylaxis (VIP) Study - VIP study | Severe form of von Willebrand disease | Trade Name: Haemate-P, Wilate Product Name: VWD factor VIII concentrate Product Code: Factor VIII | Centre of Thrombosis and Haemostasis | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Sweden | |||
| 153 | EUCTR2005-004435-22-FR (EUCTR) | 01/09/2007 | 27/03/2007 | Incidence of inhibitors in previously untreated patient with severe haemophilia A treated with Octanate (Phase III) - Etude AVI 4-03 | Incidence 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Czech Republic;France | ||
| 154 | NCT00555555 (ClinicalTrials.gov) | September 2007 | 7/11/2007 | Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients | A Post-marketing Observation Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human,) Alphanate(R), in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 Von Willebrand Disease | Von Willebrand Disease | Biological: Alphanate SD/HT | Grifols Biologicals, LLC | NULL | Active, not recruiting | 7 Years | N/A | All | 15 | Phase 4 | United States |
| 155 | NCT00557908 (ClinicalTrials.gov) | June 2007 | 13/11/2007 | The Von Willebrand Disease (VWD) International Prophylaxis Study | The VWD International Prophylaxis (VIP) Study | Von Willebrand Disease | Drug: VWF/FVIII products | Skane University Hospital | Blood Center of Wisconsin;CSL Behring | Completed | N/A | N/A | All | 105 | N/A | United States;Sweden |
| 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 |
| 156 | NCT00404300 (ClinicalTrials.gov) | February 2007 | 27/11/2006 | Optivate in People With Von Willebrand Disease Undergoing Surgery | An 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 | Drug: Optivate | Bio Products Laboratory | NULL | Terminated | 12 Years | N/A | Both | 25 | Phase 3 | Israel;United Kingdom |
| 157 | EUCTR2006-000664-85-GB (EUCTR) | 19/12/2006 | 07/12/2006 | An 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 | An 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 disease | Trade Name: Optivate Product Name: Optivate Product Code: N/A | Bio Products Laboratory | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 3 | Poland;United Kingdom | ||
| 158 | EUCTR2005-001426-84-FR (EUCTR) | 14/12/2006 | 23/10/2006 | Clinical 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 | Clinical 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Czech Republic;Germany;France | |||
| 159 | EUCTR2006-002857-54-DE (EUCTR) | 10/11/2006 | 10/08/2006 | International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD) | International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD) | von Willebrand Jürgends syndrom in children under 6 years of age | Trade Name: WILATE Product Name: Wiloctin | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Germany | |||
| 160 | NCT00387192 (ClinicalTrials.gov) | November 2006 | 11/10/2006 | A Study With OPTIVATE® in People With Von Willebrand Disease | An 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 Willebrand Disease | Drug: Optivate | Bio Products Laboratory | NULL | Terminated | 12 Years | N/A | Both | 26 | Phase 3 | Israel;United Kingdom |
| 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 |
| 161 | EUCTR2006-000663-28-GB (EUCTR) | 28/09/2006 | 22/02/2008 | An 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 | An 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 Disease | Trade Name: Optivate Product Name: Optivate | Bio Products Laboratory | NULL | Not Recruiting | Female: yes Male: yes | 26 | Phase 3 | Poland;United Kingdom | ||
| 162 | EUCTR2006-001383-23-IT (EUCTR) | 30/06/2006 | 28/11/2006 | 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 - PRO.WILL | 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 - 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 BONOMI | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 163 | EUCTR2005-004496-38-DK (EUCTR) | 22/06/2006 | 09/05/2006 | Desmopressin 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, Copenhagen | NULL | Not Recruiting | Female: yes Male: yes | 150 | Denmark | |||
| 164 | NCT00306670 (ClinicalTrials.gov) | April 2006 | 23/3/2006 | Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A | A 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 A | Hemophilia A | Drug: Rituxan;Drug: prednisone | Georgetown University | Genentech, Inc. | Terminated | 18 Years | 65 Years | All | 2 | Phase 2;Phase 3 | United States |
| 165 | EUCTR2005-001426-84-DE (EUCTR) | 09/02/2006 | 21/10/2005 | CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE | CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE | Inherited von Willebrand Disease MedDRA version: 8.0;Level: PT;Classification code 10047715 | Trade Name: WILATE Product Name: Wilate | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Germany;France | |||
| 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 |
| 166 | NCT00168077 (ClinicalTrials.gov) | September 2005 | 12/9/2005 | Prothrombin Complex Concentrate for Anticoagulant Reversal | Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation | Acquired Coagulation Factor Deficiency | Drug: Prothrombin Complex Concentrate | CSL Behring | NULL | Completed | 18 Years | N/A | Both | 40 | Phase 3 | Austria;Germany;Hungary;Israel;Lithuania;Netherlands;Poland;Switzerland |
| 167 | EUCTR2004-004868-69-SE (EUCTR) | 25/04/2005 | 09/03/2005 | Study 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 | Study 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 LLC | NULL | Not Recruiting | Female: yes Male: yes | 30 | Sweden | |||
| 168 | EUCTR2004-005051-34-BE (EUCTR) | 18/04/2005 | 31/05/2007 | Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE | Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE | Von Willebrand disease Classification code 10047715 | Trade Name: WILFACTIN Product Name: WILFACTIN Product Code: VWF SD-35-DH INN or Proposed INN: human von Willebrand factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 15 | Belgium | |||
| 169 | EUCTR2005-001746-17-BE (EUCTR) | 13/04/2005 | 12/11/2007 | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | von Willebrand disease Classification code 10047715 | Trade Name: WILFACTIN Product Name: WILFACTIN Product Code: VWF SD-35-DH INN or Proposed INN: Human von Willebrand Factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 4 | Belgium | ||
| 170 | EUCTR2004-004868-69-AT (EUCTR) | 07/03/2005 | 31/01/2005 | Study 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 | Study 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 LLC | NULL | Not Recruiting | Female: yes Male: yes | 30 | Austria;Sweden | |||
| 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 |
| 171 | NCT02250508 (ClinicalTrials.gov) | December 2004 | 2/9/2014 | A 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 Disease | Biological: Optivate® (Human Coagulation Factor VIII);Biological: Haemate P® (Human Coagulation Factor VIII) | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | Phase 2 | Israel | |
| 172 | NCT00151125 (ClinicalTrials.gov) | July 2004 | 6/9/2005 | Phase II Study of IL-11 (Neumega) in Von Willebrand Disease | Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease | Von Willebrand Disease | Drug: recombinant interleukin-11 | University of Pittsburgh | Wyeth is now a wholly owned subsidiary of Pfizer;University of North Carolina | Completed | 18 Years | N/A | Both | 12 | Phase 2 | United States |
| 173 | NCT00056589 (ClinicalTrials.gov) | March 2003 | 18/3/2003 | Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency | A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | NULL | Completed | 18 Years | N/A | All | 11 | Phase 1 | United States |
| 174 | NCT00168090 (ClinicalTrials.gov) | October 2001 | 12/9/2005 | Study 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 Disease | Drug: Blood coagulation Factor VIII and vWF, human | CSL Behring | NULL | Completed | N/A | N/A | Both | 30 | Phase 4 | United States |
| 175 | NCT02246881 (ClinicalTrials.gov) | October 2001 | 2/9/2014 | A 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 Disease | Biological: Optivate® (Human Coagulation Factor VIII) | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | Phase 3 | Poland;United Kingdom | |
| 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 |
| 176 | NCT00111215 (ClinicalTrials.gov) | January 2001 | 18/5/2005 | Treatment and Management of Women With Bleeding Disorders | Treatment and Management of Women With Bleeding Disorders | Menorrhagia;Blood Coagulation Disorders;Blood Platelet Disorders;Von Willebrand Disease;Hematologic Disease | Drug: Tranexamic Acid;Drug: Desmopressin Acetate | Centers for Disease Control and Prevention | NULL | Completed | 18 Years | 50 Years | Female | 100 | N/A | United States |
| 177 | NCT00640289 (ClinicalTrials.gov) | January 2000 | 17/3/2008 | Clinical Trial of Factor XIII (FXIII) Concentrate | Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency | Hemophilia;Factor XIII Deficiency | Drug: Fibrogammin P | Children's Hospital of Orange County | CSL Behring | Completed | N/A | N/A | All | 72 | N/A | United States |
| 178 | NCT00004667 (ClinicalTrials.gov) | October 1993 | 24/2/2000 | Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease | Von Willebrand's Disease | Drug: von Willebrand factor | National Center for Research Resources (NCRR) | University of North Carolina | Completed | N/A | N/A | Both | 10 | Phase 1 | NULL | |
| 179 | EUCTR2005-001746-17-PL (EUCTR) | 20/01/2009 | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS | von Willebrand disease MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease | Trade Name: WILFACTIN Product Name: WILFACTIN Product Code: VWF SD-35-DH INN or Proposed INN: Human von Willebrand Factor | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | Belgium;Poland | |||
| 180 | EUCTR2018-004675-13-BG (EUCTR) | 27/02/2019 | Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease. | CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) | Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Octapharma AG | NULL | NA | Female: yes Male: yes | 28 | Phase 3 | Belarus;Hungary;Czech Republic;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | ||||
| 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 |
| 181 | EUCTR2014-003764-20-Outside-EU/EEA (EUCTR) | 11/03/2015 | An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Congenital Factor XIII deficiency MedDRA version: 17.1;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cluvot INN or Proposed INN: Factor XIII Concentrate (Human) | CSL Behring LLC | NULL | NA | Female: yes Male: yes | 61 | United States | ||||
| 182 | EUCTR2006-000663-28-PL (EUCTR) | 05/11/2007 | An 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 | An 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 Laboratory | NULL | NA | Female: yes Male: yes | 26 | Phase 3 | Poland;United Kingdom | |||
| 183 | EUCTR2019-002023-15-BE (EUCTR) | 08/11/2019 | 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 | NA | 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 | |||
| 184 | EUCTR2006-000664-85-PL (EUCTR) | 24/10/2007 | An 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 | An 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 Laboratory | NULL | NA | Female: yes Male: yes | 25 | Phase 3 | Poland;United Kingdom | |||
| 185 | 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: 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) | 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;Germany;Netherlands;Japan;Korea, Republic of | |||
| 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 |
| 186 | EUCTR2009-017753-34-BG (EUCTR) | 13/10/2011 | This 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Bulgaria;Germany | |||
| 187 | EUCTR2013-003305-25-PL (EUCTR) | 10/11/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | |||
| 188 | EUCTR2014-005401-20-Outside-EU/EEA (EUCTR) | 30/01/2015 | An 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 Limited | NULL | NA | Female: yes Male: yes | 23 | Australia | ||||
| 189 | EUCTR2016-001478-14-GB (EUCTR) | 10/11/2016 | A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand disease | A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONALMULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXISWITH rVWF IN SEVERE VON WILLEBRAND DISEASE - rVWF IN PROPHYLAXIS | Hereditary severe 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 MedDRA version: 19.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant von Willebrand Factor 650IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Recombinant von Willebrand Factor 1300IU Product Code: BAX 111 INN or Proposed INN: Vonicog alfa Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: ADVATE 500 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA Trade Name: ADVATE 1000 IU powder and solvent for solution for injection Product Name: Advate INN or Proposed INN: OCTOCOG ALFA | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 3 | United States;France;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden |