288. 自己免疫性後天性凝固因子欠乏症[自己免疫性出血病XIII (~2017.3)]
[臨床試験数:189,薬物数:219(DrugBank:29),標的遺伝子数:18,標的パスウェイ数:26

Searched query = "Autoimmune acquired coagulation factor deficiency", "Coagulation factor deficiency", "Factor XIII deficiency", "Factor VIII deficiency", "Acquired hemophilia A", "von Willebrand Disease", "Factor V deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04567511
(ClinicalTrials.gov)
March 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.Not yet recruiting5 Years45 YearsMale40Phase 4NULL
2NCT04344860
(ClinicalTrials.gov)
February 1, 20219/4/2020Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN TrialProspective, Randomized Trial Comparing Recombinant Von Willebrand Factor (rVWF) Plus Tranexamic Acid vs. rVWF Alone to Reduce Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN TrialVon Willebrand Diseases;Postpartum HemorrhageDrug: Recombinant Von Willebrand factor;Drug: Tranexamic Acid Injection [Cyklokapron]Margaret RagniNULLNot yet recruiting18 YearsN/AFemale20Phase 3United States
3NCT04119908
(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
4NCT04580407
(ClinicalTrials.gov)
December 15, 20205/10/2020Efficacy and Safety Evaluation of B-Domain Deleted Recombinant Porcine Factor VIII (rpFVIII, TAK-672), in Japanese Participants With Acquired Hemophilia A (AHA)A 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-672TakedaNULLNot yet recruiting18 YearsN/AAll5Phase 2;Phase 3Japan
5EUCTR2018-004675-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04052698
(ClinicalTrials.gov)
June 18, 20209/8/2019Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWDClinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With Von Willebrand Disease (VWD)Von Willebrand DiseasesDrug: WilateOctapharmaNULLRecruiting6 YearsN/AAll28Phase 3United States;Belarus;Bulgaria;Croatia;Hungary;Lebanon;Russian Federation;Ukraine;Moldova, Republic of
7JPRN-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.NULLrecruiting18BOTH11Phase 3Japan
8ChiCTR2000035067
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
9NCT04188639
(ClinicalTrials.gov)
May 20204/12/2019Emicizumab 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 SchoolNot yet recruiting18 YearsN/AAll51Phase 2NULL
10EUCTR2019-002023-15-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 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 – vonWillebrand 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 – vonWillebrand 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 – vonWillebrand 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
Bioverativ Therapeutics Inc. (a Sanofi company)NULLAuthorised-recruitment may be ongoing or finishedFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04165135
(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 RocheNULLRecruiting12 Years50 YearsAll150Italy
12NCT04158648
(ClinicalTrials.gov)
February 10, 20207/11/2019A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII InhibitorsA Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII InhibitorsMild Hereditary Factor VIII Deficiency Disease Without Inhibitor;Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor;Hemophilia ADrug: EmicizumabHoffmann-La RocheNULLRecruitingN/AN/AAll70Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom
13EUCTR2019-002023-15-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 3United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
14EUCTR2019-002023-15-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]
Bioverativ Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
15EUCTR2018-003453-16-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;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Czech Republic;Canada;Belgium;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-002023-15-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: 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
Bioverativ Therapeutics Inc. (a Sanofi company)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
17EUCTR2019-002023-15-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]
Bioverativ Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
164Phase 3United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
18EUCTR2019-002023-15-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 3United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan
19EUCTR2019-002023-15-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: 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
Bioverativ Therapeutics Inc. (a Sanofi company)NULLAuthorised-recruitment may be ongoing or finishedFemale: 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
20NCT04161495
(ClinicalTrials.gov)
December 4, 20195/11/2019A 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 AA 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 AFactor VIII DeficiencyDrug: BIVV001Bioverativ, a Sanofi companyNULLRecruiting12 YearsN/AAll150Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04106908
(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
22NCT04146376
(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
23EUCTR2018-003453-16-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]
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany
24EUCTR2018-003453-16-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
64Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany
25NCT04053699
(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 productsOctapharmaNULLActive, not recruiting66 MonthsN/AAll35United States;Belarus;Bulgaria;Croatia;Hungary;Lebanon;Russian Federation;Ukraine;Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-004675-13-HU
(EUCTR)
04/06/201905/04/2019Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease. CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1
MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Octapharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
28Phase 3Belarus;United States;Czech Republic;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
27EUCTR2018-003453-16-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]
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany
28EUCTR2018-003453-16-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 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]
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Netherlands;Germany
29NCT03879135
(ClinicalTrials.gov)
April 1, 201920/12/2018rVWF Pediatric and Adult StudyA 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 DiseaseBiological: rVWF;Biological: rFVIIIBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruitingN/AN/AAll64Phase 3United States;France;Italy;Netherlands;Russian Federation;Spain;Turkey
30EUCTR2018-001631-46-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
Erasmus University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03782025
(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/AAll51Sweden
32NCT02606045
(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 UniversityRecruiting13 Years45 YearsFemale60Phase 3United States
33NCT03876301
(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
34NCT03700229
(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
35NCT03634215
(ClinicalTrials.gov)
August 15, 20181/7/2018Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in TraumaEstimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in TraumaMultiple Trauma;Coagulation Disorder;Coagulation Factor Deficiency;Coagulation Defect; AcquiredDiagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activityMasaryk Hospital Krajská zdravotní a.s.NULLUnknown status18 YearsN/AAll200NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-001477-33-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 and P/0214/2015 and P/0394/2019 - 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands
37NCT03613584
(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
38EUCTR2016-001477-33-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
39EUCTR2016-001477-33-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
40EUCTR2016-001478-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT02973087
(ClinicalTrials.gov)
December 22, 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)Baxalta now part of ShireBaxalta Innovations GmbH, now part of ShireCompleted18 YearsN/AAll23Phase 3United States;Canada;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey
42NCT02932618
(ClinicalTrials.gov)
December 18, 201712/10/2016BAX 111 rVWF in PediatricsA 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 ShireBaxalta Innovations GmbH, now part of ShireRecruitingN/A17 YearsAll34Phase 3United States;Austria;Belgium;Czechia;France;Germany;Italy;Netherlands;Russian Federation;Spain;Turkey;Ukraine;United Kingdom
43EUCTR2017-003036-37-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
68Phase 2Austria
44NCT03384277
(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 LeiQilu Hospital of Shandong University;Tianjin First Central Hospital;The Second Affiliated Hospital of Kunming Medical University;Henan Cancer HospitalRecruiting18 Years80 YearsAll100Phase 3China
45EUCTR2016-001478-14-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 3United States;Finland;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2016-001478-14-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
47EUCTR2016-001478-14-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
48EUCTR2016-001477-33-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
49EUCTR2016-001478-14-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
50EUCTR2016-000789-53-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2016-001477-33-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 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]
Trade Name: VEYVONDI 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 1300IU 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;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany
52EUCTR2016-001477-33-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 3United States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands
53EUCTR2016-001477-33-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
54EUCTR2016-001478-14-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 3France;United States;Czech Republic;Canada;Finland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
55EUCTR2016-001477-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2016-001478-14-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
57NCT03199794
(ClinicalTrials.gov)
December 14, 201623/6/2017Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life PracticeProspective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life PracticeAcquired Hemophilia ABiological: OBIZURBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruiting18 YearsN/AAll50United States;Austria;France;Germany;Italy;Netherlands;United Kingdom
58EUCTR2016-001477-33-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.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;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands
59NCT03006965
(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
60NCT01651468
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2013-003305-25-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Greece;Ireland;United Kingdom
62NCT02610127
(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
63NCT03871764
(ClinicalTrials.gov)
December 1, 20158/3/2019Prediction of Outcome in Severe PreeclampsiaRelation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of PreeclampsiaLeiden Factor V Deficiency,Preeclampsia;Doppler Examination;Palental PathologyDiagnostic Test: blood sample , doppler of uterine vessel and placentaCairo UniversityNULLCompletedN/AN/AFemale100NULL
64NCT04657887
(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 BehringNULLRecruitingN/AN/AAll120France
65EUCTR2013-003305-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT02552576
(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
67EUCTR2013-003305-25-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
68EUCTR2013-003305-25-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
69EUCTR2013-003305-25-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
70EUCTR2013-003305-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2014-003575-38-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
72NCT02283268
(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
73EUCTR2014-003575-38-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
74EUCTR2014-003575-38-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
75EUCTR2014-003575-38-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2014-003575-38-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
77EUCTR2014-003575-38-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]
Baxalta Innovations GmbHNULLNot Recruiting Female: yes
Male: yes
15Phase 3United States;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Argentina;Australia;Germany;Netherlands
78EUCTR2014-003575-38-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
79EUCTR2013-003240-23-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
80NCT02472665
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2012-003450-92-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
82EUCTR2006-001383-23-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
83NCT01968655
(ClinicalTrials.gov)
September 201321/10/2013Expanded 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/AAllN/AUnited States
84EUCTR2010-024108-84-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
85EUCTR2011-000181-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2010-024108-84-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]
Baxter Innovations GmbHNULLNot Recruiting Female: yes
Male: yes
40Phase 3United States;Spain;Austria;United Kingdom;Italy;India;France;Canada;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
87EUCTR2006-001383-23-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
88EUCTR2011-000181-34-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
89EUCTR2011-000181-34-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
90EUCTR2011-000181-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2006-001383-23-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]
Prof Flora Peyvandi, MDNULLNot Recruiting Female: yes
Male: yes
24Phase 3Spain;Germany;Italy;United Kingdom
92EUCTR2010-024108-84-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
93EUCTR2010-024108-84-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
94EUCTR2010-024108-84-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
95EUCTR2010-021162-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2010-023666-46-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
97EUCTR2009-017301-11-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
98NCT01410227
(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
99EUCTR2010-024108-84-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
100EUCTR2010-024108-84-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2010-024108-84-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
102EUCTR2010-024108-84-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
103NCT01800435
(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
104EUCTR2010-021162-30-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
105EUCTR2011-000181-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT01365546
(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
107NCT01178294
(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
108NCT01224808
(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
109EUCTR2009-017301-11-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
110EUCTR2009-016869-28-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
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
6Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2009-017301-11-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
112EUCTR2010-020192-23-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
113NCT01213446
(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
114EUCTR2009-017753-34-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
115EUCTR2007-004116-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2008-007883-41-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
117NCT00994929
(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
118EUCTR2009-017060-17-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
119EUCTR2008-007883-41-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
120EUCTR2008-007883-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2009-010722-19-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 3bSpain
122EUCTR2008-007883-41-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
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
60Phase 3France;Finland;Spain;Austria;Germany;Italy;United Kingdom
123NCT00978380
(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
124NCT00945906
(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
125EUCTR2008-007883-41-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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Finland;United Kingdom;Germany;France;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2008-007883-41-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
127EUCTR2008-007883-41-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
128NCT00885742
(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
129EUCTR2009-010387-41-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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Spain
130NCT00941616
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT01994330
(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
132NCT00883090
(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
133EUCTR2008-004922-18-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
134EUCTR2008-008532-82-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
135EUCTR2007-004116-32-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 BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Belgium;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT00816660
(ClinicalTrials.gov)
December 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
137EUCTR2008-000795-24-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
138NCT00694785
(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
139EUCTR2006-003148-51-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
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
45Phase 3France;Finland;Spain;Austria;Germany;Italy;United Kingdom
140EUCTR2006-003148-51-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT00713648
(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
142EUCTR2006-003148-51-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
143EUCTR2006-003148-51-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/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Finland;Germany;United Kingdom;France;Spain;Italy;Austria
144EUCTR2006-003148-51-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
145EUCTR2008-001910-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2006-003148-51-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
147NCT00524225
(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
148NCT00524342
(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
149NCT00632242
(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
150EUCTR2005-001426-84-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2007-004371-19-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
152EUCTR2007-004943-31-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
153EUCTR2005-004435-22-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
154NCT00555555
(ClinicalTrials.gov)
September 20077/11/2007Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand PatientsA Post-marketing Observation Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human,) Alphanate(R), 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
155NCT00557908
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT00404300
(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
157EUCTR2006-000664-85-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
158EUCTR2005-001426-84-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Czech Republic;Germany;France
159EUCTR2006-002857-54-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
160NCT00387192
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2006-000663-28-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
162EUCTR2006-001383-23-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
163EUCTR2005-004496-38-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
150Denmark
164NCT00306670
(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
165EUCTR2005-001426-84-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT00168077
(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
167EUCTR2004-004868-69-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
168EUCTR2004-005051-34-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
169EUCTR2005-001746-17-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
170EUCTR2004-004868-69-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT02250508
(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
172NCT00151125
(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
173NCT00056589
(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
174NCT00168090
(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
175NCT02246881
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT00111215
(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
177NCT00640289
(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
178NCT00004667
(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
179EUCTR2016-001478-14-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
180EUCTR2019-002023-15-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: 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
Bioverativ Therapeutics Inc. (a Sanofi company)NULLAuthorised-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;Germany;Netherlands;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2019-002023-15-BE
(EUCTR)
08/11/2019A 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.NULLNAFemale: 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
182EUCTR2014-005401-20-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
183EUCTR2006-000664-85-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
184EUCTR2005-001746-17-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
185EUCTR2009-017753-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2006-000663-28-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
187EUCTR2018-004675-13-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 WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1
MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Octapharma AGNULLNA Female: yes
Male: yes
28Phase 3Belarus;Hungary;Czech Republic;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria
188EUCTR2013-003305-25-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
189EUCTR2014-003764-20-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