Reveglucosidase alpha ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
256筋型糖原病3

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 133 - (DrugBank : 29) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 105
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-001768-48-AT
(EUCTR)
21/02/201612/01/2016A Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects with Late-onset Pompe DiseaseA Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects with Late-onset Pompe Disease Pompe disease
MedDRA version: 18.1;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMN 701
Product Code: BMN 701
INN or Proposed INN: reveglucosidase alpha
Other descriptive name: GILT-rhGAA
Product Name: BMN 701
Product Code: BMN 701
INN or Proposed INN: reveglucosidase alpha
Other descriptive name: GILT-rhGAA
BioMarin Pharmaceutical IncNULLNot RecruitingFemale: yes
Male: yes
70Phase 3Portugal;France;United States;Belgium;Austria;Netherlands;Germany;Japan;Italy;United Kingdom;Switzerland
2EUCTR2013-001768-48-DE
(EUCTR)
23/09/201422/05/2014A Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects with Late-onset Pompe DiseaseA Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects with Late-onset Pompe Disease Pompe disease
MedDRA version: 18.1;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMN 701
Product Code: BMN 701
INN or Proposed INN: reveglucosidase alpha
Other descriptive name: GILT-rhGAA
Product Name: BMN 701
Product Code: BMN 701
INN or Proposed INN: reveglucosidase alpha
Other descriptive name: GILT-rhGAA
BioMarin Pharmaceutical IncNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Portugal;France;United States;Argentina;Belgium;Austria;Netherlands;Colombia;Germany;Japan;Italy;United Kingdom
3EUCTR2013-001768-48-BE
(EUCTR)
08/09/201412/05/2014A Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects with Late-onset Pompe DiseaseA Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects with Late-onset Pompe Disease Pompe disease
MedDRA version: 18.0;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMN 701
Product Code: BMN 701
INN or Proposed INN: reveglucosidase alpha
Other descriptive name: GILT-rhGAA
Product Name: BMN 701
Product Code: BMN 701
INN or Proposed INN: reveglucosidase alpha
Other descriptive name: GILT-rhGAA
BioMarin Pharmaceutical IncNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Portugal;France;United States;Argentina;Belgium;Austria;Netherlands;Germany;Colombia;Japan;Italy;United Kingdom