288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 206 / 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
| 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 | 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 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 | Not Recruiting | Female: yes Male: yes | 28 | Phase 3 | United States;Belarus;Czech Republic;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | ||
| 3 | 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 | ||
| 4 | EUCTR2020-004344-28-DE (EUCTR) | 22/08/2022 | Clinical study to find out how well wilate works in little children with severe von Willebrand disease | CLINICAL STUDY TO INVESTIGATE THE EFFICACY, PHARMACOKINETICS, IMMUNOGENICITY AND SAFETY OF WILATE IN SEVERE VON WILLEBRAND DISEASE PATIENTS UNDER THE AGE OF 6 YEARS | Routine prophylaxis in children under the age of 6 years with severe VWD 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 Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND HUMAN COAGULATION FACTOR Trade Name: Wilate 1000 Product Name: Wilate INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND HUMAN COAGULATION FACTOR | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | NA | Female: yes Male: yes | 12 | Phase 3 | Belarus;United States;Czechia;Czech Republic;Canada;Ukraine;Russian Federation;North Macedonia;Albania;Germany;Moldova, Republic of;Bosnia and Herzegovina | |||
| 5 | 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 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 | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria |