ADVATE (rAHF-PFM) ( DrugBank: rAHF )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
288自己免疫性後天性凝固因子欠乏症9

288. 自己免疫性後天性凝固因子欠乏症


臨床試験数 : 206 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-024108-84-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
2EUCTR2010-024108-84-ES
(EUCTR)
11/06/201202/04/2012Clinical study to explore the influence of the human body on the study drug, on the safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD Von Willebrand Disease
MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: rVWF
Product Code: BAX111
INN or Proposed INN: vonicog alfa
Trade Name: ADVATE (rAHF-PFM)
Product Name: ADVATE (rAHF - PFM)
Product Code: not applicable
INN or Proposed INN: OCTOCOG ALFA
Baxter Innovations GmbHNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;United Kingdom;Italy;India;France;Canada;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Sweden
3EUCTR2010-024108-84-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
4EUCTR2010-024108-84-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
5EUCTR2010-024108-84-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
6EUCTR2010-024108-84-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
7EUCTR2010-024108-84-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
8EUCTR2010-024108-84-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
9EUCTR2010-024108-84-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