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17

288. 自己免疫性後天性凝固因子欠乏症


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.TrialIDDate_
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PhaseCountries
1NCT04953884
(ClinicalTrials.gov)
July 28, 202118/6/2021Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of AgeClinical Study to Investigate the Efficacy, Pharmacokinetics, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease Patients Under the Age of 6 YearsVon Willebrand DiseaseDrug: wilateOctapharmaNULLRecruitingN/A5 YearsAll12Phase 3United States;Belarus;Czechia;Moldova, Republic of;North Macedonia;Russian Federation;Ukraine
2EUCTR2018-004675-13-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
3NCT04146376
(ClinicalTrials.gov)
October 12, 201929/10/2019Von Willebrand Factor in Pregnancy (VIP) StudyVon Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for ChildbirthVon Willebrand DiseasesOther: 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.BloodworksMary M. Gooley Hemophilia Center;Ergomed;OctapharmaRecruiting18 YearsN/AFemale110United States
4EUCTR2018-004675-13-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 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
28Phase 3United States;Belarus;Czech Republic;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
5EUCTR2018-001631-46-NL
(EUCTR)
14/02/201913/02/2019Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand diseaseImplementation 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
Trade Name: Veyvondi
INN or Proposed INN: VON WILLEBRAND FACTOR
Other descriptive name: VON WILLEBRAND FACTOR
Erasmus University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Netherlands
6EUCTR2010-021162-30-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
7EUCTR2010-021162-30-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
8NCT01365546
(ClinicalTrials.gov)
June 201127/5/2011Wilate in Subjects With Von Willebrand Disease Who Undergo SurgeryProspective, 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 ProceduresPrevent Bleeding in Major SurgeryBiological: human VWF/FVIII concentrateOctapharmaNULLCompleted6 YearsN/AAll30Phase 3United States;Bulgaria;India;Italy;Oman;Poland;Romania;South Africa;Turkey
9EUCTR2008-000795-24-SE
(EUCTR)
06/10/200815/08/2008Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOMESurveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOME von Willebrand diseaseTrade Name: WilateOctapharma AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Sweden
10EUCTR2008-001910-25-SK
(EUCTR)
17/07/200813/05/2008Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over studyPharmacokinetics 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 AGNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Slovakia
11EUCTR2005-001426-84-CZ
(EUCTR)
06/12/200716/10/2007CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASECLINICAL 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: WilateOctapharma AGNULLNot RecruitingFemale: yes
Male: yes
20Germany;Czech Republic;France
12EUCTR2007-004943-31-SE
(EUCTR)
03/10/200712/09/2007The VWD International Prophylaxis (VIP) Study - VIP studyThe VWD International Prophylaxis (VIP) Study - VIP study Severe form of von Willebrand diseaseTrade Name: Haemate-P, Wilate
Product Name: VWD factor VIII concentrate
Product Code: Factor VIII
Centre of Thrombosis and HaemostasisNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Sweden
13EUCTR2005-001426-84-FR
(EUCTR)
14/12/200623/10/2006Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD) - WIL-14Clinical 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 AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 2France;Czech Republic;Germany
14EUCTR2006-002857-54-DE
(EUCTR)
10/11/200610/08/2006International 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 ageTrade Name: WILATE
Product Name: Wiloctin
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
50Germany
15EUCTR2005-001426-84-DE
(EUCTR)
09/02/200621/10/2005CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASECLINICAL 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 AGNULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Germany;France
16EUCTR2020-004344-28-DE
(EUCTR)
22/08/2022Clinical study to find out how well wilate works in little children with severe von Willebrand diseaseCLINICAL 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.NULLNAFemale: yes
Male: yes
12Phase 3Belarus;United States;Czechia;Czech Republic;Canada;Ukraine;Russian Federation;North Macedonia;Albania;Germany;Moldova, Republic of;Bosnia and Herzegovina
17EUCTR2018-004675-13-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