Recombinant human alpha-galactosidase abbreviated as r-h-alpha-GAL ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
19ライソゾーム病5

19. ライソゾーム病


臨床試験数 : 899 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-005668-28-FR
(EUCTR)
12/10/200916/03/2009A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose)A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose) Fabry disease
MedDRA version: 9.1;Level: LLT;Classification code 10016016;Term: Fabry's disease
Trade Name: Fabrazyme
Product Name: Fabrazyme
Product Code: Agalsidase beta
INN or Proposed INN: agalsidase beta
Other descriptive name: recombinant human alpha-galactosidase abbreviated as r-h-alpha-GAL
Genzyme Europe BVNULLNot RecruitingFemale: no
Male: yes
45Phase 3Portugal;France;Czech Republic;Germany;Netherlands;United Kingdom
2EUCTR2007-005668-28-CZ
(EUCTR)
27/11/200810/12/2008A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose)A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose) Fabry disease
MedDRA version: 9.1;Level: LLT;Classification code 10016016;Term: Fabry's disease
Trade Name: Fabrazyme
Product Name: Fabrazyme
Product Code: Agalsidase beta
INN or Proposed INN: agalsidase beta
Other descriptive name: recombinant human alpha-galactosidase abbreviated as r-h-alpha-GAL
Genzyme Europe BVNULLNot RecruitingFemale: no
Male: yes
45Phase 3France;Portugal;Czech Republic;Germany;Netherlands;United Kingdom
3EUCTR2007-005668-28-DE
(EUCTR)
19/11/200804/08/2008A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose)A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose) Fabry disease
MedDRA version: 9.1;Level: LLT;Classification code 10016016;Term: Fabry's disease
Trade Name: Fabrazyme 35 mg
Product Name: Fabrazyme
Product Code: Agalsidase beta
INN or Proposed INN: agalsidase beta
Other descriptive name: recombinant human alpha-galactosidase abbreviated as r-h-alpha-GAL
Trade Name: Fabrazyme 5 mg
Product Name: Fabrazyme
Product Code: Agalsidase beta
INN or Proposed INN: agalsidase beta
Other descriptive name: recombinant human alpha-galactosidase abbreviated as r-h-alpha-GAL
Genzyme Europe BVNULLNot RecruitingFemale: no
Male: yes
45Phase 3Portugal;Czech Republic;United Kingdom;Germany;Netherlands;France
4EUCTR2007-005668-28-PT
(EUCTR)
03/10/200815/07/2008A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose)A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose) Fabry disease
MedDRA version: 9.1;Level: LLT;Classification code 10016016;Term: Fabry's disease
Trade Name: Fabrazyme
Product Name: Fabrazyme
Product Code: Agalsidase beta
INN or Proposed INN: agalsidase beta
Other descriptive name: recombinant human alpha-galactosidase abbreviated as r-h-alpha-GAL
Genzyme Europe BVNULLNot RecruitingFemale: no
Male: yes
45Phase 3Portugal;Czech Republic;Germany;United Kingdom;Netherlands;France
5EUCTR2007-005668-28-NL
(EUCTR)
04/09/200802/06/2008A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose)A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms - FIELD (Fabrazyme: Intervening Early at a Lower Dose) Fabry disease
MedDRA version: 9.1;Level: LLT;Classification code 10016016;Term: Fabry's disease
Trade Name: Fabrazyme
Product Name: Fabrazyme
Product Code: Agalsidase beta
INN or Proposed INN: agalsidase beta
Other descriptive name: recombinant human alpha-galactosidase abbreviated as r-h-alpha-GAL
Genzyme Europe BVNULLNot RecruitingFemale: no
Male: yes
24Phase 3France;Portugal;Czech Republic;Germany;Netherlands;United Kingdom