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.TrialIDDate_
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PhaseCountries
1NCT05582993
(ClinicalTrials.gov)
January 9, 202314/10/2022A Study of Recombinant Von Willebrand Factor (rVWF) (TAK-577) in Children With Severe Von Willebrand Disease (vWD)A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis With rVWF in Children Diagnosed With Severe Von Willebrand DiseaseVon Willebrand Disease (VWD)Biological: Recombinant von Willebrand Factor (rVWF);Biological: ADVATETakedaNULLNot yet recruitingN/A17 YearsAll24Phase 3NULL
2NCT05500807
(ClinicalTrials.gov)
November 1, 202212/8/2022Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia AEmicizumab for Severe VON Willebrand Disease (VWD) and VWD/Hemophilia AVon Willebrand Disease, Type 3;Concomitant VWD and HemophiliaDrug: EmicizumabBleeding and Clotting Disorders Institute Peoria, IllinoisGenentech, Inc.Recruiting2 Years90 YearsAll40Phase 1United States
3NCT05345197
(ClinicalTrials.gov)
August 31, 202218/4/2022Emicizumab in Patients With Acquired Hemophilia AEmicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical TrialAcquired Hemophilia ADrug: emicizumabUniversity of WashingtonGenentech, Inc.Recruiting18 YearsN/AAll51Phase 2United States
4NCT04580407
(ClinicalTrials.gov)
November 9, 20215/10/2020Study of TAK-672 in Participants With Acquired Hemophilia AA 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 ABiological: TAK-672TakedaNULLCompleted18 YearsN/AAll5Phase 2/Phase 3Japan
5NCT04567511
(ClinicalTrials.gov)
September 1, 202129/7/2020Hemlibra in Mild Hemophilia AProspective, Single-Arm, Open-Label Use of Hemlibra (Emicizumab) in the Treatment of Mild Hemophilia AFactor VIII Deficiency, CongenitalDrug: EmicizumabIndiana Hemophilia &Thrombosis Center, Inc.Genentech, Inc.Recruiting5 Years45 YearsMale40Phase 4United States
6NCT04953884
(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
7EUCTR2019-004430-42-AT
(EUCTR)
22/06/202122/04/2021Evaluation of the effect of emicizumab in patients suffering from acute bleeds with previously no family history.Emicizumab in Patients with Acquired Hemophilia A: Multicenter, Single-Arm, Open-Label Clinical Trial Acquired Hemophilia A (AHA)
MedDRA version: 22.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851
MedDRA version: 20.0;Classification code 10053760;Term: Acquired hemophilia;System Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Hemlibra®
INN or Proposed INN: Emicizumab
Other descriptive name: RO5534262 EMICIZUMAB
GWT-TUD GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
47Phase 2Austria;Germany
8NCT04188639
(ClinicalTrials.gov)
March 23, 20214/12/2019Emicizumab in Acquired Hemophilia AEmicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical TrialHemophilia A, AcquiredDrug: Emicizumab InjectionGWT-TUD GmbHHoffmann-La Roche;Hannover Medical SchoolCompleted18 YearsN/AAll47Phase 2Austria;Germany
9EUCTR2019-004430-42-DE
(EUCTR)
25/01/202120/11/2020Evaluation of the effect of emicizumab in patients suffering from acute bleeds with previously no family history.Emicizumab in Patients with Acquired Hemophilia A: Multicenter, Single-Arm, Open-Label Clinical Trial Acquired Hemophilia A (AHA)
MedDRA version: 22.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851
MedDRA version: 20.0;Classification code 10053760;Term: Acquired hemophilia;System Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Hemlibra®
INN or Proposed INN: Emicizumab
Other descriptive name: RO5534262 EMICIZUMAB
GWT-TUD GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
47Phase 2Austria;Germany
10NCT04119908
(ClinicalTrials.gov)
January 20217/10/2019Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic DiseasesInterest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic DiseasesVon Willebrand Diseases;Glanzmann ThrombastheniaDevice: Sublingual videomicroscopy;Biological: blood sampleUniversity Hospital, LilleNULLNot yet recruiting18 YearsN/AAll400N/ANULL
11EUCTR2018-004675-13-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
12JPRN-JapicCTI-205151
15/6/202007/02/2020PHASE 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 AIntervention 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.NULLcomplete18BOTH11Phase 3Japan
13ChiCTR2000035067
2020-05-112020-07-30A 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 CollegeNULLRecruitingBothCase series:20;Phase 4China
14EUCTR2019-002023-15-IT
(EUCTR)
17/04/202017/06/2021A 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 = or >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)]
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)]
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)]
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR -
Product Name: Recombinant coagulation FVIII Fc –von Willebrand factor – XTEN fusion protein
Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)]
Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTO
BIOVERATIV THERAPEUTICS INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
15EUCTR2019-002023-15-DE
(EUCTR)
25/02/202009/10/2019A 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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
16NCT04165135
(ClinicalTrials.gov)
February 24, 202031/10/2019An 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 TreatmentA 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 TreatmentSevere Hereditary Factor VIII Deficiency Disease Without Inhibitor;Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor;Haemophilia ADrug: Standard of Care for Haemophilia AHoffmann-La RocheNULLCompleted12 Years50 YearsAll107Italy
17EUCTR2019-002023-15-FR
(EUCTR)
06/02/202004/11/2019A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3Colombia;Argentina;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Netherlands;Belgium;Taiwan;Brazil;Italy;Mexico;France;Australia;Bulgaria;Germany
18EUCTR2019-002023-15-ES
(EUCTR)
28/01/202002/12/2019A 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.NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
19EUCTR2018-003453-16-AT
(EUCTR)
23/01/202021/10/2019A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Germany;Netherlands
20EUCTR2019-002023-15-BG
(EUCTR)
22/01/202006/11/2019A 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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
21EUCTR2019-002023-15-HU
(EUCTR)
21/01/202020/11/2019A 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.NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
22EUCTR2019-002023-15-GB
(EUCTR)
06/01/202010/10/2019NA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3Argentina;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Netherlands;Belgium;Taiwan;Brazil;Italy;Mexico;Australia;Bulgaria;France;Germany;Colombia
23EUCTR2019-002023-15-GR
(EUCTR)
27/12/201913/11/2019A 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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
24NCT04106908
(ClinicalTrials.gov)
November 27, 201928/8/2019Effectiveness and Tolerability of Eqwilate in Real-life ConditionsMOdalities 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 StudyVWD - Von Willebrand's DiseaseBiological: EqwilateOctapharmaNULLRecruiting6 YearsN/AAll47France
25NCT04146376
(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
26EUCTR2018-003453-16-IT
(EUCTR)
07/08/201922/01/2021A 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 PEDIATRICAND 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]
Trade Name: VEYVONDI 650IU powder and solvent for solution for injection
Product Name: VONICOG Alfa
Product Code: [NA]
INN or Proposed INN: VONICOG ALFA
Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection
Product Name: VONICOG ALFA
Product Code: [na]
INN or Proposed INN: VONICOG ALFA
Trade Name: ADVATE 500 IU powder and solvent for solution for injection
Product Name: Advate
Product Code: [na]
INN or Proposed INN: OCTOCOG ALFA
Trade Name: ADVATE 1000 IU powder and solvent for solution for injection
Product Name: Advate
Product Code: [na]
INN or Proposed INN: OCTOCOG ALFA
BAXALTA INNOVATIONS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Germany;Netherlands
27EUCTR2018-003453-16-FR
(EUCTR)
31/07/201911/01/2019A 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]
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 GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany
28EUCTR2018-003453-16-DE
(EUCTR)
28/06/201918/02/2019A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
71Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Germany;Netherlands
29NCT04053699
(ClinicalTrials.gov)
June 25, 201923/7/2019Bleeding Incidence in VWD Patients Undergoing On-Demand TreatmentA Prospective, Multicenter, Non-Interventional Study Evaluating the Bleeding Incidence in Patients With Von Willebrand Disease Undergoing On-Demand TreatmentVon Willebrand DiseasesDrug: VWF-containing productsOctapharmaNULLCompleted66 MonthsN/AAll35United States;Belarus;Bulgaria;Croatia;Hungary;Lebanon;Russian Federation;Ukraine;Moldova, Republic of
30EUCTR2018-004675-13-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
31EUCTR2018-003453-16-ES
(EUCTR)
10/05/201927/05/2019A 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]
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 GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany
32EUCTR2018-003453-16-NL
(EUCTR)
11/04/201928/01/2019A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Netherlands;Germany
33NCT03879135
(ClinicalTrials.gov)
April 1, 201920/12/2018A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)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 (VWD)Biological: rVWF;Biological: rFVIIIBaxalta now part of ShireTakeda Development Center Americas, Inc.RecruitingN/AN/AAll71Phase 3United States;Austria;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey
34EUCTR2018-001631-46-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
35NCT03782025
(ClinicalTrials.gov)
February 13, 201918/12/2018Effect of Vitamin K in Critically Ill PatientsEffect of Vitamin K in Critically Ill Patients With Spontaneously Increased Pro-thrombin Time Measured With Routine Coagulation Tests and Advanced Coagulation- and Vitamin K-assaysCoagulation Factor Deficiency;Coagulopathy, Consumption;Vitamin K DeficiencyDrug: PhytomenadioneRegion SkaneNULLCompleted18 YearsN/AAll52Sweden
36NCT02606045
(ClinicalTrials.gov)
February 7, 20195/11/2015Minimize Menorrhagia in Women With Von Willebrand DiseaseProspective, 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 StudyVon Willebrand DiseasesDrug: recombinant von Willebrand factor;Drug: tranexamic acidMargaret RagniUniversity of North Carolina;Duke University;National Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting13 Years45 YearsFemale60Phase 3United States
37NCT03876301
(ClinicalTrials.gov)
January 21, 201911/3/2019Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A ParticipantsA Multi-Center, Observational Study in Males With Hemophilia ABlood Coagulation Disorder;Blood Coagulation Disorders, Inherited;Coagulation Protein Disorders;Hemophilia A;Genetic Diseases, Inborn;Genetic Diseases, X-Linked;Hematologic Diseases;Hemorrhagic Disorders;Factor VIII DeficiencyDrug: Standard of Care FVIII Replacement therapySpark TherapeuticsNULLActive, not recruiting18 YearsN/AMale55United States;Australia;Canada;Thailand
38NCT03700229
(ClinicalTrials.gov)
October 10, 20184/10/2018Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia AAn Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia AAcquired Hemophilia ADrug: Bortezomib;Drug: RituximabPeking Union Medical College HospitalNULLUnknown status18 YearsN/AAll22Phase 2China
39EUCTR2016-001477-33-DE
(EUCTR)
12/06/201827/07/2017A 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 , P/0214/2015 , P/0394/2019 and P/0463/2020 - 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
34Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands
40NCT03613584
(ClinicalTrials.gov)
April 16, 201822/3/2018Von Willebrand Factor Concentrate During ECMO SupportA Double-blind, Placebo-controlled Pilot Trial to Investigate the Administration of Von Willebrand Factor Concentrate (Willfact®, LFB France) in Adult Patients During Extracorporeal Membrane OxygenationAcquired Von Willebrand DiseaseDrug: Von Willebrand Factor;Drug: Saline SolutionTirol Kiniken GmbHLFB BIOMEDICAMENTSActive, not recruiting18 YearsN/AAll68Phase 2Austria
41EUCTR2016-001477-33-NL
(EUCTR)
12/04/201811/01/2018A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Netherlands;Germany
42EUCTR2016-001477-33-FR
(EUCTR)
12/03/201821/02/2017A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany
43NCT03161626
(ClinicalTrials.gov)
February 27, 201818/5/2017Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major SurgeryA Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major SurgeryFactor 10 DeficiencyDrug: CoagadexBio Products LaboratoryNULLCompleted12 YearsN/AAll3United States
44EUCTR2016-001478-14-FR
(EUCTR)
14/02/201821/03/2017A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
18Phase 3United States;France;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
45NCT02932618
(ClinicalTrials.gov)
December 18, 201712/10/2016A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)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 DiseaseVon Willebrand DiseaseBiological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)Baxalta now part of ShireTakeda Development Center Americas, Inc.RecruitingN/A17 YearsAll34Phase 3United States;Austria;Belgium;Czechia;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey;Ukraine;United Kingdom
46NCT02973087
(ClinicalTrials.gov)
November 16, 201722/11/2016rVWF IN PROPHYLAXISA PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASEVon Willebrand DiseaseBiological: von Willebrand factor (Recombinant);Biological: Antihemophilic Factor (Recombinant)TakedaBaxalta Innovations GmbH, now part of ShireCompleted18 YearsN/AAll29Phase 3United States;Canada;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey
47EUCTR2017-003036-37-AT
(EUCTR)
27/10/201714/09/2017The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machineA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
68Phase 2Austria
48NCT03384277
(ClinicalTrials.gov)
October 26, 201728/11/2017Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With RituximabA Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With RituximabAcquired Hemophilia ADrug: Steroid;Drug: Rituximab;Drug: CyclophosphamideZhang Lei, MDQilu Hospital of Shandong University;Tianjin First Central Hospital;The Second Affiliated Hospital of Kunming Medical University;Henan Cancer HospitalCompleted18 Years80 YearsAll66Phase 4China
49NCT02869074
(ClinicalTrials.gov)
October 3, 201729/7/2016Molecular and Clinical Profile of Von Willebrand Disease in SpainMolecular and Clinical Profile of Von Willebrand Disease (VWD) in Spain (PCM-EVW-ES). Recruitment Extension, Further Data Analysis, Improvement of Registry Platform, Diagnosis and Management of VWD Application DevelopmentVon Willebrand DiseaseGenetic: VWF gene analysisSpanish Society of Thrombosis and HaemostasisFrancisco Vidal Pérez;Maria Fernanda López Fernández;Almudena Pérez Rodríguez;Irene Corrales Insa;Ana Rosa Cid HaroRecruiting2 Years80 YearsAll400Spain
50EUCTR2016-001478-14-FI
(EUCTR)
14/08/201703/01/2017A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
22Phase 3United States;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Denmark;Germany;Netherlands
51EUCTR2016-001478-14-DE
(EUCTR)
24/07/201703/01/2017A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
22Phase 3United States;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Sweden
52EUCTR2016-001478-14-NL
(EUCTR)
13/06/201708/12/2016A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
22Phase 3United States;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Denmark;Netherlands;Germany
53EUCTR2016-001477-33-CZ
(EUCTR)
05/04/201707/12/2016A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands
54EUCTR2016-001478-14-CZ
(EUCTR)
13/03/201707/12/2016A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
18Phase 3France;United States;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
55EUCTR2016-000789-53-AT
(EUCTR)
09/03/201717/10/2016The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machineA 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 IntensivmedizinNULLNot RecruitingFemale: yes
Male: yes
Phase 2Austria
56EUCTR2016-001477-33-BE
(EUCTR)
27/02/201729/11/2016A 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, P/0214/2015, P/0394/2019 and P/0463/2020 - 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
Trade Name: VEYVONDI 1300I IU 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands
57EUCTR2016-001477-33-GB
(EUCTR)
22/02/201707/11/2016A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3Russian Federation;United States;Ukraine;United Kingdom;Spain;Canada;Austria;Czech Republic;Netherlands;Turkey;Belgium;Finland;Poland;Italy;France;Germany
58EUCTR2016-001477-33-ES
(EUCTR)
14/02/201727/12/2016A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany
59EUCTR2016-001478-14-ES
(EUCTR)
14/02/201727/12/2016A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
18Phase 3United States;France;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
60EUCTR2016-001477-33-IT
(EUCTR)
06/02/201702/11/2016A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany
61EUCTR2016-001478-14-IT
(EUCTR)
31/01/201730/11/2016A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
18Phase 3Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States
62EUCTR2016-001477-33-AT
(EUCTR)
01/12/201627/10/2016A 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. - 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
Trade Name: VEYVONDI 1300 IU 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany
63NCT03006965
(ClinicalTrials.gov)
November 11, 201622/12/2016Pharmacokinetic 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 AlgorithmHemophilia A;Hemophilia;Factor VIII DeficiencyDrug: octocog alfa;Drug: rurioctocog alfa pegolSpanish Society of Thrombosis and HaemostasisTakeda;Instituto de Investigación Hospital Universitario La PazRecruiting1 Year65 YearsMale100Spain
64NCT01651468
(ClinicalTrials.gov)
September 201625/7/2012The Effect of the Nutraceutical Hemofix on the Coagulation SystemPhase 1 Study of the Nutraceutical Hemofix Safety and Effect on the Coagulation SystemVon Willebrand Disease;MenorrhagiaDietary Supplement: HEMOFIXHadassah Medical OrganizationHEMOFIX;Yocheved Grossman;Idan GrossmanWithdrawn18 Years75 YearsAll0Phase 1Israel
65EUCTR2013-003305-25-GR
(EUCTR)
02/02/201617/12/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
66NCT02610127
(ClinicalTrials.gov)
December 30, 201529/10/2015Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia APost-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia AAcquired Hemophilia ABiological: OBIZURBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireCompleted18 YearsN/AAll53United States
67NCT04657887
(ClinicalTrials.gov)
November 23, 20151/12/2020Registry of Patients With Von WilLEbrand Disease Treated With Voncento®Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento®Von Willebrand DiseaseBiological: Voncento®CSL BehringNULLActive, not recruitingN/AN/AAll135France
68EUCTR2013-003305-25-DE
(EUCTR)
19/11/201502/06/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Germany;United Kingdom;Greece;Poland;Ireland;Austria
69NCT02552576
(ClinicalTrials.gov)
October 5, 201515/9/2015Study of Voncento® in Subjects With Von Willebrand DiseaseAn Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects With Von Willebrand DiseaseVon Willebrand DiseaseBiological: VoncentoCSL BehringNULLCompletedN/AN/AAll26Phase 4Austria;Germany;Greece;Poland;United Kingdom;Ireland
70EUCTR2013-003305-25-AT
(EUCTR)
22/09/201525/06/2015An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
71EUCTR2013-003305-25-PT
(EUCTR)
11/09/201519/08/2015An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Portugal;Ireland;United Kingdom
72EUCTR2013-003305-25-IE
(EUCTR)
03/09/201509/07/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
73EUCTR2013-003305-25-GB
(EUCTR)
07/07/201505/05/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Germany;United Kingdom;Greece;Poland;Ireland;Austria
74EUCTR2014-003575-38-NL
(EUCTR)
09/04/201509/12/2014A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
15Phase 3United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Netherlands;Germany
75NCT02283268
(ClinicalTrials.gov)
April 1, 201527/10/2014Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing SurgeryA 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 DiseaseVon Willebrand DiseaseBiological: Recombinant von Willebrand Factor (rVWF)Baxalta now part of ShireNULLCompleted18 YearsN/AAll24Phase 3United States;Australia;Austria;Czechia;Germany;Italy;Netherlands;Russian Federation;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic
76NCT01721681
(ClinicalTrials.gov)
April 201525/10/2012A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 YearsA Phase III Open, Multicentre Study to Investigate the Safety, Pharmacokinetics and Efficacy of BPL's High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of 12 YearsFactor X DeficiencyBiological: FACTOR XBio Products LaboratoryNULLCompletedN/A11 YearsAll9Phase 3United Kingdom
77EUCTR2014-003575-38-DE
(EUCTR)
25/03/201522/12/2014A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
15Phase 3United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Germany;Netherlands
78EUCTR2012-003093-98-GB
(EUCTR)
24/02/201502/01/2013The purpose of this study is to look at how well FACTOR X works in preventing bleeding when taken regularly in children aged under 12 years old, over a period of 6 months. The study will also look at how safe FACTOR X is by closely following the subjects progress during the study.A Phase III Open, Multicentre Study to Confirm the Safety, Pharmacokinetics and Efficacy of BPL’s High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of 12 Years Factor X Deficiency;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: Human factor X
Product Code: FACTOR X
INN or Proposed INN: Human Coagulation Factor X
Other descriptive name: FACTOR X
Bio Products Laboratory LimitedNULLNot RecruitingFemale: yes
Male: yes
8Phase 3Turkey;United Kingdom
79EUCTR2014-003575-38-IT
(EUCTR)
27/01/201517/11/2014A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
15Phase 3United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Australia;Germany;Netherlands
80EUCTR2014-003575-38-CZ
(EUCTR)
26/01/201519/11/2014A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
15Phase 3United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Australia;Germany;Netherlands
81EUCTR2014-003575-38-ES
(EUCTR)
26/01/201516/12/2014A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
15Phase 3United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Argentina;Australia;Germany;Netherlands
82EUCTR2014-003575-38-GB
(EUCTR)
15/01/201526/11/2014A 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 GmbHNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Argentina;Australia;Germany;Netherlands
83EUCTR2014-003575-38-AT
(EUCTR)
07/01/201510/11/2014A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
15Phase 3United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Australia;Germany;Netherlands
84NCT01968655
(ClinicalTrials.gov)
September 9, 201421/10/2013Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesExpanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesAcquired Hemophilia ABiological: OBI-1Baxalta now part of ShireNULLNo longer available18 YearsN/AAllUnited States
85EUCTR2013-003240-23-IE
(EUCTR)
09/12/201310/10/2013To 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' HospitalNULLNot RecruitingFemale: no
Male: yes
Ireland
86NCT02472665
(ClinicalTrials.gov)
December 201310/6/2015Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand DiseaseEvaluation 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 DiseaseVon Willebrand DiseaseDrug: plasma-derived FVIII/VWF concentrateGrifols Therapeutics LLCInstituto Grifols, S.A.Recruiting2 Months6 YearsAll8Phase 4Spain
87EUCTR2012-003450-92-ES
(EUCTR)
23/11/201329/11/2012Evaluation 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: FanhdiInstituto Grifols S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8Spain
88EUCTR2006-001383-23-DE
(EUCTR)
19/09/201321/05/2013Efficacy, 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 bleedingsEfficacy, 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 PoliclinicoNULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
89NCT02460458
(ClinicalTrials.gov)
November 5, 201227/5/2015Type 3 Von Willebrand International Registries Inhibitor Prospective StudyType 3 Von Willebrand International Registries Inhibitor Prospective StudyType 3 Von Willebrand's DiseaseDrug: Von Willebrand FactorFondazione Angelo Bianchi BonomiSintesi Research SrlActive, not recruitingN/AN/AAll265Finland;France;Germany;Hungary;Iran, Islamic Republic of;Italy;Netherlands;Spain;Sweden;United Kingdom
90EUCTR2010-024108-84-BG
(EUCTR)
20/08/201226/09/2011Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
91EUCTR2011-000181-34-DE
(EUCTR)
27/06/201209/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
92EUCTR2010-024108-84-ES
(EUCTR)
11/06/201202/04/2012Clinical 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]
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 GmbHNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;United Kingdom;Italy;India;France;Canada;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
93EUCTR2006-001383-23-ES
(EUCTR)
24/05/201201/03/2012Efficacy, 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 PoliclinicoNULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
94EUCTR2011-000181-34-IT
(EUCTR)
20/05/201207/08/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy 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 BIOPHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;United Kingdom;Italy;Sweden;India
95EUCTR2011-000181-34-SE
(EUCTR)
10/05/201207/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;India;Sweden
96EUCTR2011-000181-34-HU
(EUCTR)
04/05/201215/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
97EUCTR2009-015086-31-ES
(EUCTR)
03/05/201227/02/2012A study for people with coagulation factor X deficiency, to assess the effectiveness and safety of a high purity factor X concentrate for people having surgery.Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery Factor X Deficiency;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: Human factor X
Product Code: FACTOR X
Other descriptive name: FACTOR X
Bio Products Laboratory LimitedNULLNot RecruitingFemale: yes
Male: yes
10Phase 3United States;Spain;Turkey;Germany;United Kingdom;India
98EUCTR2006-001383-23-GB
(EUCTR)
19/04/201213/01/2010Efficacy, 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: Alphanate
Product Name: Alphanate 1000 I.U.
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Trade Name: Alphanate
Product Name: Alphanate 1500 I.U.
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Prof Flora Peyvandi, MDNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Germany;Italy;United Kingdom
99EUCTR2010-024108-84-NL
(EUCTR)
19/03/201231/08/2011Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;France;Canada;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden
100EUCTR2010-024108-84-DE
(EUCTR)
26/01/201208/08/2011Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
101EUCTR2010-024108-84-BE
(EUCTR)
22/12/201108/09/2011Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
102EUCTR2010-021162-30-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
103EUCTR2010-023666-46-PL
(EUCTR)
13/12/201120/12/2011A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERYEFFICACY 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 BIOTECHNOLOGIESNULLNot RecruitingFemale: no
Male: yes
Poland
104EUCTR2009-017301-11-DE
(EUCTR)
17/11/201113/07/2011This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
26Poland;Ukraine;Bulgaria;Russian Federation;Germany
105NCT01410227
(ClinicalTrials.gov)
November 1, 20114/8/2011Pharmacokinetics, 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 DiseaseVon Willebrand DiseaseBiological: Recombinant von Willebrand factor (rVWF);Drug: Placebo;Biological: Recombinant factor VIIII (rFVIII)Baxalta now part of ShireNULLCompleted18 Years65 YearsAll49Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Germany;India;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;France
106EUCTR2010-024108-84-GB
(EUCTR)
31/10/201105/08/2011Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
107EUCTR2010-024108-84-IT
(EUCTR)
25/10/201101/03/2012Clinical 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 GMBHNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Italy;United Kingdom;India;Canada;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden
108EUCTR2010-024108-84-SE
(EUCTR)
10/10/201112/08/2011Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;India
109EUCTR2010-024108-84-AT
(EUCTR)
06/10/201123/08/2011Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
49Phase 3United States;Spain;Austria;Russian Federation;United Kingdom;Italy;India;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;Japan;Sweden
110NCT01800435
(ClinicalTrials.gov)
October 201115/2/2013A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With InhibitorWhole 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 StudyHereditary Factor VIII Deficiency Disease With InhibitorDrug: aPCC, aPCC + TXA;Drug: rFVIIa, rFVIIa + TXAOslo University HospitalNULLCompleted18 Years65 YearsMale6Phase 4Norway
111EUCTR2010-021162-30-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
112EUCTR2011-000181-34-GB
(EUCTR)
29/06/201123/06/2011Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
113NCT01365546
(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
114NCT01086852
(ClinicalTrials.gov)
March 201110/11/2009Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing SurgeryA Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL's High Purity FACTOR X in the Treatment of Factor X Deficient Subjects Undergoing SurgeryFactor X DeficiencyBiological: FACTOR XBio Products LaboratoryNULLTerminated12 YearsN/AAll4Phase 3United States;Spain;Turkey;United Kingdom;Germany
115NCT01178294
(ClinicalTrials.gov)
November 10, 20106/8/2010Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia AEfficacy 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-antibodiesAcquired Hemophilia ABiological: OBI-1Baxalta now part of ShireNULLCompleted18 YearsN/AAll29Phase 2/Phase 3United States;Canada;India;United Kingdom;France;Germany;Hungary;Italy;Sweden
116NCT01224808
(ClinicalTrials.gov)
October 20108/6/2010Extension Study of Biostate in Subjects With Von Willebrand DiseaseAn 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-08-54Von Willebrand DiseaseBiological: BiostateCSL BehringNULLCompletedN/AN/AAll20Phase 3Bulgaria;Germany;Poland;Russian Federation;Ukraine
117EUCTR2009-017301-11-PL
(EUCTR)
29/09/201018/08/2010This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
26Poland;Ukraine;Bulgaria;Russian Federation;Germany
118EUCTR2009-011145-18-DE
(EUCTR)
21/09/201001/04/2010A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency - A PK study of BPL's FX in patients with FX deficiencyA Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency - A PK study of BPL's FX in patients with FX deficiency Factor X deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10052474;Term: Factor X deficiency
Product Name: Human factor X
Product Code: FACTOR X
Other descriptive name: Human factor X
Bio Products Laboratory LimitedNULLNot RecruitingFemale: yes
Male: yes
16Phase 3Spain;Germany;United Kingdom
119EUCTR2009-016869-28-GB
(EUCTR)
20/09/201007/07/2010A 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 DeficiencyA 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
Product Name: Recombinant factor XIII (rFXIII)
Product Code: NN 1841
INN or Proposed INN: Catridecacog
Other descriptive name: Recombinant factor XIII (rFXIII)
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
6 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
120EUCTR2009-017301-11-BG
(EUCTR)
20/09/201025/06/2010This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
26Poland;Ukraine;Russian Federation;Bulgaria;Germany
121EUCTR2010-020192-23-GB
(EUCTR)
20/09/201006/08/2010A 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-3760A 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/SNULLNot RecruitingFemale: yes
Male: yes
6France;Finland;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
122NCT01213446
(ClinicalTrials.gov)
August 20101/10/2010Study of Biostate® in Children With Von Willebrand DiseaseA Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects With Von Willebrand DiseaseVon Willebrand DiseaseBiological: BiostateCSL BehringParexelCompletedN/A12 YearsAll17Phase 3Belarus;Georgia;Germany;Guatemala;Lebanon;Ukraine;Mexico
123EUCTR2009-017753-34-DE
(EUCTR)
09/07/201015/01/2010This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
12Phase 3Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Germany
124EUCTR2007-004116-32-BE
(EUCTR)
11/05/201027/07/2009CLINICAL 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 SURGERYEFFICACY 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 BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
18Phase 3France;Belgium
125EUCTR2009-015086-31-GB
(EUCTR)
16/03/201017/03/2010A study for people with coagulation factor X deficiency, to assess the effectiveness and safety of a high purity factor X concentrate for people having surgery.Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery Factor X Deficiency;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: Human factor X
Product Code: FACTOR X
Other descriptive name: FACTOR X
Bio Products Laboratory LimitedNULLNot RecruitingFemale: yes
Male: yes
10Phase 3United States;Spain;Turkey;Germany;United Kingdom;India
126EUCTR2008-007883-41-AT
(EUCTR)
15/03/201025/01/2010A 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/SNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;Italy;United Kingdom
127NCT00994929
(ClinicalTrials.gov)
January 201012/10/2009Efficacy and Safety of IL-11 in DDAVP UnresponsivePhase 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 DDAVPHemophilia A;Von Willebrand DiseaseBiological: Neumega (Oprelvekin, Interleukin 11, IL-11)University of PittsburghNULLCompleted18 YearsN/AAll9Phase 2United States
128NCT00930176
(ClinicalTrials.gov)
January 201010/6/2009A Study Investigating Treatment Factor X in People With Factor X DeficiencyA Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.Factor X DeficiencyBiological: Human Coagulation FACTOR XBio Products LaboratoryNULLCompleted12 YearsN/AAll16Phase 3United States;Germany;Spain;Turkey;United Kingdom
129EUCTR2009-017060-17-NL
(EUCTR)
10/12/200905/11/2009STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII - STIMULATESTIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII - STIMULATE Type 1 von Willebrand disease and mild hemophilia ATrade Name: simvastatine
Product Name: simvastatin
INN or Proposed INN: SIMVASTATIN
Trade Name: Minrin
Product Name: Desmopressine
INN or Proposed INN: DESMOPRESSIN
Academic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
Netherlands
130EUCTR2009-011145-18-ES
(EUCTR)
07/12/200902/10/2009A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.Estudio de fase III, multicéntrico y abierto que investiga la farmacocinética, la seguridad y la eficacia del factor X de alta pureza de BPL en el tratamiento de la deficiencia del factor X grave y moderada. - A PK study of BPL's FX in patients with FX deficiencyA Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.Estudio de fase III, multicéntrico y abierto que investiga la farmacocinética, la seguridad y la eficacia del factor X de alta pureza de BPL en el tratamiento de la deficiencia del factor X grave y moderada. - A PK study of BPL's FX in patients with FX deficiency Factor X deficiency.Deficiencia de Factor X
MedDRA version: 12.0;Level: LLT;Classification code 10052474;Term: Factor X deficiency
Product Name: Human factor X
Product Code: FACTOR X
Other descriptive name: Human factor X
Bio Products LaboratoryNULLNot RecruitingFemale: yes
Male: yes
16Phase 3Spain;Germany;United Kingdom
131EUCTR2008-007883-41-IT
(EUCTR)
27/11/200931/12/2009A 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-3720A 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 NORDISKNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;United Kingdom;Italy
132EUCTR2008-007883-41-ES
(EUCTR)
16/11/200905/10/2009Ensayo 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/SNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;Italy;United Kingdom
133EUCTR2009-010722-19-ES
(EUCTR)
04/11/200911/08/2009A 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 XIIIA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Spain
134EUCTR2008-007883-41-GB
(EUCTR)
04/11/200923/07/2009 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
Product Name: Recombinant factor XIII (rFXIII)
INN or Proposed INN: Catridecacog
Other descriptive name: Recombinant factor XIII (rFXIII)
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Finland;Spain;Austria;Germany;Italy;United Kingdom
135EUCTR2009-011145-18-GB
(EUCTR)
02/11/200924/09/2009A study for people with severe and moderate coagulation factor X deficiency, to assess the effectiveness and safety of a high purity factor X concentrate, and how it is handled by the body.A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency - A PK study of BPL's FX in patients with FX deficiency Factor X deficiency
MedDRA version: 14.1;Level: PT;Classification code 10052474;Term: Factor X deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Human factor X
Product Code: FACTOR X
INN or Proposed INN: Human coagulation Factor X
Other descriptive name: Human factor X
Bio Products Laboratory LtdNULLNot RecruitingFemale: yes
Male: yes
16Phase 3United States;Spain;Turkey;Germany;United Kingdom
136NCT00978380
(ClinicalTrials.gov)
September 21, 200915/9/2009Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725A 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 DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNULLCompleted6 YearsN/AAll63Phase 3United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Japan;Spain;Switzerland;United Kingdom
137NCT00945906
(ClinicalTrials.gov)
September 200923/7/2009An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human) (FXIII)CSL BehringNULLCompletedN/AN/AAll61Phase 3United States
138EUCTR2008-007883-41-FI
(EUCTR)
13/08/200915/06/2009A 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™2A 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/SNULLNot RecruitingFemale: yes
Male: yes
60France;Finland;Spain;Austria;Germany;Italy;United Kingdom
139EUCTR2008-007883-41-FR
(EUCTR)
13/08/200905/08/2009A 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/SNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;Finland;Spain;Austria;Germany;Italy;United Kingdom
140EUCTR2008-007883-41-DE
(EUCTR)
04/08/200922/06/2009A 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™2A 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/SNULLNot RecruitingFemale: yes
Male: yes
60France;Finland;Spain;Austria;Germany;Italy;United Kingdom
141NCT00885742
(ClinicalTrials.gov)
August 200921/4/2009A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human)CSL BehringNULLCompletedN/AN/AAll41Phase 3United States;Spain
142EUCTR2009-010387-41-ES
(EUCTR)
25/06/200916/04/2009A 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 XIIIA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
15Phase 2Spain
143NCT00941616
(ClinicalTrials.gov)
June 200915/7/2009Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand DiseaseAn Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects With Von Willebrand Disease.Von Willebrand DiseaseBiological: Biostate®CSL BehringParexelCompleted12 YearsN/AAll22Phase 2/Phase 3Bulgaria;Poland;Russian Federation;Ukraine;Brazil
144NCT01994330
(ClinicalTrials.gov)
June 200914/11/2013Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement SurgerySevere Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement SurgeryAcquired Von Willebrand Disease Secondary to Severe Aortic Stenosis;Heye´s Syndrome;Severe Aortic StenosisDrug: desmopressinPontificia Universidad Catolica de ChileFerring PharmaceuticalsCompletedN/AN/AAll13Phase 4Chile
145NCT00883090
(ClinicalTrials.gov)
May 200916/4/2009A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII DeficiencyA 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human)CSL BehringNULLCompletedN/AN/AAll15Phase 2United States;Spain
146EUCTR2008-004922-18-BG
(EUCTR)
16/04/200913/04/2009An 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Bulgaria
147EUCTR2008-008532-82-AT
(EUCTR)
19/02/200921/01/2009A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2BA 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 2BProduct Name: ARC1779
Product Code: ARC1779
Medical University of Vienna, Dept. of Clinical PharmacologyNULLNot RecruitingFemale: yes
Male: yes
Austria
148EUCTR2007-004116-32-FR
(EUCTR)
03/12/200812/03/2009EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NAEFFICACY 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 BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
18Phase 3France;Belgium
149NCT00816660
(ClinicalTrials.gov)
December 1, 20082/1/2009Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand DiseaseRecombinant 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 DiseaseBiological: Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII);Biological: Marketed plasma-derived VWF/FVIII concentrateBaxalta now part of ShireNULLCompleted18 Years60 YearsAll32Phase 1United States;Austria;Canada;Germany;Italy;United Kingdom
150EUCTR2008-000795-24-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
151NCT00694785
(ClinicalTrials.gov)
October 20086/6/2008A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2BA Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2BVon Willebrand DiseaseDrug: ARC1779Archemix Corp.NULLWithdrawn16 Years75 YearsBoth2Phase 2NULL
152EUCTR2006-003148-51-FI
(EUCTR)
15/08/200824/06/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45Finland;Germany;United Kingdom;France;Spain;Italy;Austria
153EUCTR2006-003148-51-GB
(EUCTR)
15/08/200809/05/2008A 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-1725A 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/SNULLNot Recruiting Female: yes
Male: yes
45 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Finland;Spain;Austria;Germany;Italy;United Kingdom
154NCT00713648
(ClinicalTrials.gov)
August 20087/7/2008Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited DeficiencyA 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 DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNULLCompleted6 YearsN/AAll41Phase 3United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Spain;Switzerland;United Kingdom
155EUCTR2006-003148-51-DE
(EUCTR)
29/07/200812/06/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45France;Finland;Spain;Austria;Germany;Italy;United Kingdom
156EUCTR2006-003148-51-FR
(EUCTR)
22/07/200822/05/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45Phase 3France;Finland;Spain;Austria;Germany;Italy;United Kingdom
157EUCTR2006-003148-51-AT
(EUCTR)
17/07/200816/06/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45Finland;Germany;United Kingdom;France;Spain;Italy;Austria
158EUCTR2008-001910-25-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
159EUCTR2006-003148-51-IT
(EUCTR)
10/07/200823/09/2008A 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-1725A 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 NORDISKNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;United Kingdom;Italy
160NCT00524225
(ClinicalTrials.gov)
February 200831/8/2007IL-11 in Adults With Von Willebrand Disease Undergoing SurgeryPhase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing SurgeryVon Willebrand DiseaseDrug: Neumega (Oprelvekin, Interleukin 11, IL-11)Margaret RagniUniversity of North Carolina;Wyeth is now a wholly owned subsidiary of PfizerTerminated18 YearsN/AAll3Phase 2United States
161NCT00524342
(ClinicalTrials.gov)
January 200831/8/2007IL-11 in Women With Von Willebrand Disease and Refractory MenorrhagiaPhase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory MenorrhagiaVon Willebrand DiseaseDrug: Oprelvekin, Interleukin 11, IL-11Margaret RagniUniversity of North Carolina;Wyeth is now a wholly owned subsidiary of PfizerCompleted18 Years45 YearsFemale7Phase 2United States
162NCT00632242
(ClinicalTrials.gov)
January 20083/3/2008ARC1779 Injection in Patients With Von Willebrand Factor-Related Platelet Function DisordersA Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients With Von Willebrand Factor-Related Platelet Function DisordersPurpura, Thrombotic Thrombocytopenic;Von Willebrand Disease Type-2bDrug: ARC1779Archemix Corp.NULLCompleted18 Years75 YearsBoth28Phase 2Austria
163EUCTR2005-001426-84-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
164EUCTR2007-004371-19-AT
(EUCTR)
20/11/200712/12/2007A Phase 2 Pilot Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 Injection in Patients with von Willebrand Factor-Related Platelet Function DisordersA 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.NULLNot RecruitingFemale: yes
Male: yes
28Phase 2Austria
165EUCTR2007-004943-31-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
166EUCTR2005-004435-22-FR
(EUCTR)
01/09/200727/03/2007Incidence of inhibitors in previously untreated patient with severe haemophilia A treated with Octanate (Phase III) - Etude AVI 4-03Incidence 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 AGNULLNot RecruitingFemale: yes
Male: yes
35Phase 3Czech Republic;France
167NCT00555555
(ClinicalTrials.gov)
September 20077/11/2007Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand PatientsA Post-marketing Observational Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human), Alphanate®, in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 Von Willebrand DiseaseVon Willebrand DiseaseBiological: Alphanate SD/HTGrifols Biologicals, LLCNULLActive, not recruiting7 YearsN/AAll15Phase 4United States
168NCT00557908
(ClinicalTrials.gov)
June 200713/11/2007The Von Willebrand Disease (VWD) International Prophylaxis StudyThe VWD International Prophylaxis (VIP) StudyVon Willebrand DiseaseDrug: VWF/FVIII productsSkane University HospitalBlood Center of Wisconsin;CSL BehringCompletedN/AN/AAll105N/AUnited States;Sweden
169NCT00404300
(ClinicalTrials.gov)
February 200727/11/2006Optivate in People With Von Willebrand Disease Undergoing SurgeryAn 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 SurgeryVon Willebrand DiseaseDrug: OptivateBio Products LaboratoryNULLTerminated12 YearsN/ABoth25Phase 3Israel;United Kingdom
170EUCTR2006-000664-85-GB
(EUCTR)
19/12/200607/12/2006An 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 SurgeryAn 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 diseaseTrade Name: Optivate
Product Name: Optivate
Product Code: N/A
Bio Products LaboratoryNULLNot RecruitingFemale: yes
Male: yes
25Phase 3Poland;United Kingdom
171EUCTR2005-001426-84-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
172EUCTR2006-002857-54-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
173NCT00387192
(ClinicalTrials.gov)
November 200611/10/2006A Study With OPTIVATE® in People With Von Willebrand DiseaseAn 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 ConcentrateVon Willebrand DiseaseDrug: OptivateBio Products LaboratoryNULLTerminated12 YearsN/ABoth26Phase 3Israel;United Kingdom
174EUCTR2006-000663-28-GB
(EUCTR)
28/09/200622/02/2008An 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 DiseaseAn 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 DiseaseTrade Name: Optivate
Product Name: Optivate
Bio Products LaboratoryNULLNot RecruitingFemale: yes
Male: yes
26Phase 3Poland;United Kingdom
175EUCTR2006-001383-23-IT
(EUCTR)
30/06/200628/11/2006Efficacy, 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.WILLEfficacy, 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 BONOMINULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
176EUCTR2005-004496-38-DK
(EUCTR)
22/06/200609/05/2006Desmopressin 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, CopenhagenNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Denmark
177NCT00306670
(ClinicalTrials.gov)
April 200623/3/2006Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia AA 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 AHemophilia ADrug: Rituxan;Drug: prednisoneGeorgetown UniversityGenentech, Inc.Terminated18 Years65 YearsAll2Phase 2/Phase 3United States
178EUCTR2005-001426-84-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
179NCT00168077
(ClinicalTrials.gov)
September 200512/9/2005Prothrombin Complex Concentrate for Anticoagulant ReversalEfficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral AnticoagulationAcquired Coagulation Factor DeficiencyDrug: Prothrombin Complex ConcentrateCSL BehringNULLCompleted18 YearsN/ABoth40Phase 3Austria;Germany;Hungary;Israel;Lithuania;Netherlands;Poland;Switzerland
180EUCTR2004-004868-69-SE
(EUCTR)
25/04/200509/03/2005Study 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 DiseaseStudy 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 LLCNULLNot RecruitingFemale: yes
Male: yes
30Sweden
181EUCTR2004-005051-34-BE
(EUCTR)
18/04/200531/05/2007Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLEEfficacy 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 BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
15Belgium
182EUCTR2005-001746-17-BE
(EUCTR)
13/04/200512/11/2007EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXISEFFICACY 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 BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
6Phase 4Belgium
183EUCTR2004-004868-69-AT
(EUCTR)
07/03/200531/01/2005Study 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 DiseaseStudy 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 LLCNULLNot RecruitingFemale: yes
Male: yes
30Austria;Sweden
184NCT02250508
(ClinicalTrials.gov)
December 20042/9/2014A 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 DiseaseBiological: Optivate® (Human Coagulation Factor VIII);Biological: Haemate P® (Human Coagulation Factor VIII)Bio Products LaboratoryNULLCompleted12 YearsN/AAllPhase 2Israel
185NCT00151125
(ClinicalTrials.gov)
July 20046/9/2005Phase II Study of IL-11 (Neumega) in Von Willebrand DiseasePhase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand DiseaseVon Willebrand DiseaseDrug: recombinant interleukin-11University of PittsburghWyeth is now a wholly owned subsidiary of Pfizer;University of North CarolinaCompleted18 YearsN/ABoth12Phase 2United States
186NCT00056589
(ClinicalTrials.gov)
March 200318/3/2003Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll DeficiencyA Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNULLCompleted18 YearsN/AAll11Phase 1United States
187NCT00168090
(ClinicalTrials.gov)
October 200112/9/2005Study 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 DiseaseDrug: Blood coagulation Factor VIII and vWF, humanCSL BehringNULLCompletedN/AN/ABoth30Phase 4United States
188NCT02246881
(ClinicalTrials.gov)
October 20012/9/2014A 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 DiseaseBiological: Optivate® (Human Coagulation Factor VIII)Bio Products LaboratoryNULLCompleted12 YearsN/AAllPhase 3Poland;United Kingdom
189NCT00111215
(ClinicalTrials.gov)
January 200118/5/2005Treatment and Management of Women With Bleeding DisordersTreatment and Management of Women With Bleeding DisordersMenorrhagia;Blood Coagulation Disorders;Blood Platelet Disorders;Von Willebrand Disease;Hematologic DiseaseDrug: Tranexamic Acid;Drug: Desmopressin AcetateCenters for Disease Control and PreventionNULLCompleted18 Years50 YearsFemale100N/AUnited States
190NCT00640289
(ClinicalTrials.gov)
January 200017/3/2008Clinical Trial of Factor XIII (FXIII) ConcentrateClinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII DeficiencyHemophilia;Factor XIII DeficiencyDrug: Fibrogammin PChildren's Hospital of Orange CountyCSL BehringCompletedN/AN/AAll72N/AUnited States
191NCT00004667
(ClinicalTrials.gov)
October 199324/2/2000Phase I Study of Human Von Willebrand Factor for Von Willebrand's DiseaseVon Willebrand's DiseaseDrug: von Willebrand factorNational Center for Research Resources (NCRR)University of North CarolinaCompletedN/AN/ABoth10Phase 1NULL
192EUCTR2005-001746-17-PL
(EUCTR)
20/01/2009EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXISEFFICACY 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 BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
15Phase 4Belgium;Poland
193EUCTR2019-002023-15-NL
(EUCTR)
25/11/2019A 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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands;Japan;Korea, Republic of
194EUCTR2018-003453-16-BE
(EUCTR)
23/06/2022A 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 GmbHNULLNAFemale: yes
Male: yes
64Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Netherlands;Germany
195EUCTR2014-003764-20-Outside-EU/EEA
(EUCTR)
11/03/2015An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA 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 LLCNULLNAFemale: yes
Male: yes
61United States
196EUCTR2014-005401-20-Outside-EU/EEA
(EUCTR)
30/01/2015An 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 LimitedNULLNAFemale: yes
Male: yes
23Australia
197EUCTR2006-000663-28-PL
(EUCTR)
05/11/2007An 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 concentrateAn 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 LaboratoryNULLNAFemale: yes
Male: yes
26Phase 3Poland;United Kingdom
198EUCTR2016-001478-14-GB
(EUCTR)
10/11/2016A study to determine the effectiveness and Safety of rVWF used to prevent bleeding episodes in patients with severe von Willebrand diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
18Phase 3United States;France;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
199EUCTR2006-000664-85-PL
(EUCTR)
24/10/2007An 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 SurgeryAn 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 LaboratoryNULLNAFemale: yes
Male: yes
25Phase 3Poland;United Kingdom
200EUCTR2016-001477-33-Outside-EU/EEA
(EUCTR)
19/12/2022A 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 Hereditary severe von Willebrand Disease in children;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Veyvondi
Trade Name: Advate
Baxalta Innovations GmbHTakeda Development Center Americas, Inc.NAFemale: yes
Male: yes
Phase 3United States;Russian Federation;Turkey;Ukraine
201EUCTR2019-002023-15-BE
(EUCTR)
08/11/2019Phase 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 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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
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: Efanesoctocog alfa
Bioverativ Therapeutics Inc. (a Sanofi company)NULLNot RecruitingFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
202EUCTR2018-004675-13-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
203EUCTR2020-004344-28-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
204EUCTR2013-003305-25-PL
(EUCTR)
10/11/2015Study of Voncento® in Subjects with Von Willebrand DiseaseAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Greece;Poland;Ireland;Austria;Germany;United Kingdom
205EUCTR2020-003304-13-IE
(EUCTR)
27/10/2022A preventive study of bleeding episodes for children with severe von Willebrand disease (VWD).A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease severe 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: 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
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
24Phase 3France;United States;Canada;Spain;Ireland;Austria;Norway;Netherlands;Italy;Japan;China;Sweden
206EUCTR2009-017753-34-BG
(EUCTR)
13/10/2011This 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
12Phase 3Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Bulgaria;Germany