Wilate (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 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)］ | 16 |
| 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 | 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 | ||
| 2 | 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 |
| 3 | 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 | |
| 4 | 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 | |||
| 5 | 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 |
| 11 | 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 | |||
| 12 | 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 | |||
| 13 | 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 | |||
| 14 | 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 | |||
| 15 | 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 |
| 16 | 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 |