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. | 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 | EUCTR2007-005668-28-FR (EUCTR) | 12/10/2009 | 16/03/2009 | 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) | 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 BV | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 3 | Portugal;France;Czech Republic;Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2007-005668-28-CZ (EUCTR) | 27/11/2008 | 10/12/2008 | 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) | 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 BV | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 3 | France;Portugal;Czech Republic;Germany;Netherlands;United Kingdom | ||
| 3 | EUCTR2007-005668-28-DE (EUCTR) | 19/11/2008 | 04/08/2008 | 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) | 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 BV | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 3 | Portugal;Czech Republic;United Kingdom;Germany;Netherlands;France | ||
| 4 | EUCTR2007-005668-28-PT (EUCTR) | 03/10/2008 | 15/07/2008 | 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) | 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 BV | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 3 | Portugal;Czech Republic;Germany;United Kingdom;Netherlands;France | ||
| 5 | EUCTR2007-005668-28-NL (EUCTR) | 04/09/2008 | 02/06/2008 | 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) | 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 BV | NULL | Not Recruiting | Female: no Male: yes | 24 | Phase 3 | France;Portugal;Czech Republic;Germany;Netherlands;United Kingdom |