Wilate 500 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
288Autoimmune acquired coagulation factor deficiency5

288. Autoimmune acquired coagulation factor deficiency


Clinical trials : 205 Drugs : 238 - (DrugBank : 31) / Drug target genes : 18 - Drug target pathways : 26
No.TrialIDDate_
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PhaseCountries
1EUCTR2018-004675-13-HR
(EUCTR)
28/11/202002/12/2020Study 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 3United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
2EUCTR2018-004675-13-HU
(EUCTR)
04/06/201905/04/2019Study 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]
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 AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
28 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Czech Republic;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
3EUCTR2010-021162-30-BG
(EUCTR)
20/12/201107/12/2011This 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 AGNULLNot RecruitingFemale: yes
Male: yes
41Phase 3United States;Turkey;Russian Federation;Bulgaria;Italy;India
4EUCTR2010-021162-30-IT
(EUCTR)
20/09/201107/03/2012Clinical 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 AGNULLNot RecruitingFemale: yes
Male: yes
41Phase 3United States;Turkey;Bulgaria;Russian Federation;Italy;India
5EUCTR2018-004675-13-BG
(EUCTR)
27/02/2019Study 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 AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 3United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria