288. Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details


Clinical trials : 205 Drugs : 238 - (DrugBank : 31) / Drug target genes : 18 - Drug target pathways : 26

  
6 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;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Germany;Netherlands
2EUCTR2018-003453-16-IT
(EUCTR)
07/08/201922/01/2021A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease.A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study severe von Willebrand Disease
MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VEYVONDI 650IU powder and solvent for solution for injection
Product Name: VONICOG Alfa
Product Code: [NA]
INN or Proposed INN: VONICOG ALFA
Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection
Product Name: VONICOG ALFA
Product Code: [na]
INN or Proposed INN: VONICOG ALFA
Trade Name: ADVATE 500 IU powder and solvent for solution for injection
Product Name: Advate
Product Code: [na]
INN or Proposed INN: OCTOCOG ALFA
Trade Name: ADVATE 1000 IU powder and solvent for solution for injection
Product Name: Advate
Product Code: [na]
INN or Proposed INN: OCTOCOG ALFA
BAXALTA INNOVATIONS GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Germany;Netherlands
3EUCTR2018-003453-16-FR
(EUCTR)
31/07/201911/01/2019A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study severe von Willebrand Disease
MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VEYVONDI 650IU powder and solvent for solution for injection
INN or Proposed INN: VONICOG ALFA
Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection
INN or Proposed INN: VONICOG ALFA
Trade Name: ADVATE 500 IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Trade Name: ADVATE 1000 IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany
4EUCTR2018-003453-16-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;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;France;Canada;Belgium;Germany;Netherlands
5EUCTR2018-003453-16-ES
(EUCTR)
10/05/201927/05/2019A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease. A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study severe von Willebrand Disease
MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VEYVONDI 650IU powder and solvent for solution for injection
INN or Proposed INN: VONICOG ALFA
Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection
INN or Proposed INN: VONICOG ALFA
Trade Name: ADVATE 500 IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Trade Name: ADVATE 1000 IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Netherlands;Germany
6EUCTR2018-003453-16-NL
(EUCTR)
11/04/201928/01/2019A study on the long-term safety and effectiveness of rVWF in children and adults diagnosed with Severe von Willebrand Disease.A PHASE 3B, PROSPECTIVE, OPEN-LABEL,UNCONTROLLED, MULTICENTER STUDY ON LONGTERMSAFETY AND EFFICACY OF rVWF IN PEDIATRICAND ADULT SUBJECTS WITH SEVERE VONWILLEBRAND DISEASE (VWD) - rVWF Pediatric and Adult Study severe von Willebrand Disease
MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VEYVONDI 650IU powder and solvent for solution for injection
INN or Proposed INN: VONICOG ALFA
Trade Name: VEYVONDI 1300IU powder and solvent for solution for injection
INN or Proposed INN: VONICOG ALFA
Trade Name: ADVATE 500 IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Trade Name: ADVATE 1000 IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
64Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Netherlands;Germany