Advate 500 iu powder and solvent for solution for injection    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
288Autoimmune acquired coagulation factor deficiency [Autoimmune Hemorrhaphilia XIII (~Mar 2017)]25

288. Autoimmune acquired coagulation factor deficiency [Autoimmune Hemorrhaphilia XIII (~Mar 2017)]    [ 189 clinical trials,   219 drugs,   (DrugBank: 29 drugs),   18 drug target genes,   26 drug target pathways]
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.
25 / 189 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003453-16-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
2EUCTR2018-003453-16-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
3EUCTR2016-001477-33-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
4EUCTR2016-001477-33-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
5EUCTR2016-001477-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-001478-14-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
7EUCTR2016-001478-14-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
8EUCTR2016-001478-14-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
9EUCTR2016-001478-14-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
10EUCTR2016-001477-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-001478-14-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
12EUCTR2016-001477-33-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
13EUCTR2016-001477-33-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
14EUCTR2016-001478-14-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
15EUCTR2016-001477-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-001477-33-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
17EUCTR2016-001478-14-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
18EUCTR2016-001477-33-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
19EUCTR2014-003575-38-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
20EUCTR2014-003575-38-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-003575-38-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
22EUCTR2014-003575-38-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
23EUCTR2014-003575-38-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
24EUCTR2014-003575-38-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
25EUCTR2016-001478-14-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