RhGAA, acid alpha glucosidase ( 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 | 5 |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2006-003644-31-DE (EUCTR) | 03/08/2007 | 11/07/2007 | An Open-Label Extension Study of Patients with Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704 | An Open-Label Extension Study of Patients with Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704 | Glycogen Storage Disease type II (Pompe's disease) MedDRA version: 9.1;Level: LLT;Classification code 10036143;Term: Pompe's disease | Trade Name: Myozyme Product Name: Myozyme Product Code: rhGAA, acid alpha glucosidase INN or Proposed INN: Alglucosidase alfa Other descriptive name: alglucosidase alpha | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 82 | Germany;Netherlands;France | |||
2 | EUCTR2006-003644-31-NL (EUCTR) | 01/08/2007 | 04/06/2007 | An Open-Label Extension Study of Patients with Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704 | An Open-Label Extension Study of Patients with Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704 | Glycogen Storage Disease type II (Pompe's disease) MedDRA version: 9.1;Level: LLT;Classification code 10036143;Term: Pompe's disease | Trade Name: Myozyme Product Name: Myozyme Product Code: rhGAA, acid alpha glucosidase INN or Proposed INN: Alglucosidase alfa Other descriptive name: alglucosidase alpha | Genzyme Europe BV | NULL | Not Recruiting | Female: yes Male: yes | 82 | Germany;Netherlands;France | |||
3 | EUCTR2006-003644-31-FR (EUCTR) | 18/01/2007 | 11/12/2006 | An Open-Label Extension Study of Patients with Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704 | An Open-Label Extension Study of Patients with Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704 | Glycogen Storage Disease type II (Pompe's disease) | Trade Name: Myozyme Product Name: Myozyme Product Code: rhGAA, acid alpha glucosidase INN or Proposed INN: Alglucosidase alfa Other descriptive name: alglucosidase alpha | Genzyme Europe BV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 4 | France;Germany;Netherlands | ||
4 | EUCTR2005-002829-31-GB (EUCTR) | 31/08/2005 | 07/07/2005 | Full title of the trial : A Single Centre, Open-Label, Bridging Study of the Safety, Pharmacokinetics and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) Treatment in Patients with Late-Onset Pompe Disease (Glycogen Storage Disease Type II) - mini LOTS | Full title of the trial : A Single Centre, Open-Label, Bridging Study of the Safety, Pharmacokinetics and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) Treatment in Patients with Late-Onset Pompe Disease (Glycogen Storage Disease Type II) - mini LOTS | Glycogen Storage Disease type II (Pompe´s disease) | Product Name: Myozyme Product Code: rhGAA, acid alpha glucosidase INN or Proposed INN: Alglucosidase alfa Other descriptive name: alglucosidase alpha | Genzyme Europe BV | NULL | Not Recruiting | Female: yes Male: yes | 5 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;United Kingdom | ||
5 | EUCTR2005-002829-31-BE (EUCTR) | 09/02/2006 | Full title of the trial : A Single Centre, Open-Label, Bridging Study of the Safety, Pharmacokinetics and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) Treatment in Patients with Late-Onset Pompe Disease (Glycogen Storage Disease Type II) - mini LOTS | Full title of the trial : A Single Centre, Open-Label, Bridging Study of the Safety, Pharmacokinetics and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) Treatment in Patients with Late-Onset Pompe Disease (Glycogen Storage Disease Type II) - mini LOTS | Glycogen Storage Disease type II (Pompe´s disease) | Product Name: Myozyme Product Code: rhGAA, acid alpha glucosidase INN or Proposed INN: Alglucosidase alfa Other descriptive name: alglucosidase alpha | Genzyme Europe BV | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 2 | Belgium;United Kingdom |