HGT-1111 ( 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 | 6 |
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 | EUCTR2008-000084-41-BE (EUCTR) | 03/03/2010 | 15/12/2009 | A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD) | A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD) | Metachromatic Leukodystrophy (MLD) in late infantile patients MedDRA version: 9.1;Level: LLT;Classification code 10024381;Term: Leukodystrophy | Product Name: HGT-1111 Product Code: rhASA Other descriptive name: recombinant human arylsulfatase A | Shire Human Genetic Therapies Inc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | France;Belgium;Denmark;Italy | ||
| 2 | EUCTR2008-000084-41-FR (EUCTR) | 01/12/2009 | 05/08/2009 | A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD) | A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD) | Metachromatic Leukodystrophy (MLD) in late infantile patients MedDRA version: 9.1;Level: LLT;Classification code 10024381;Term: Leukodystrophy | Product Name: HGT-1111 Product Code: rhASA Other descriptive name: recombinant human arylsulfatase A | Shire Human Genetic Therapies Inc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | France;Belgium;Denmark;Italy | ||
| 3 | EUCTR2008-000084-41-IT (EUCTR) | 25/08/2009 | 11/08/2009 | A Multi-center, Open-Label Extension Study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) Treatment in Patients with Late Infantile Metachromatic Leukodystrophy (MLD) - ND | A Multi-center, Open-Label Extension Study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) Treatment in Patients with Late Infantile Metachromatic Leukodystrophy (MLD) - ND | metachromatic leukodystrophy (MLD) in late infantile patients MedDRA version: 9.1;Level: PT;Classification code 10024381 | Product Name: HGT-1111 | Shire Human Genetic Therapies Inc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | France;Belgium;Denmark;Italy | ||
| 4 | EUCTR2008-000084-41-DK (EUCTR) | 15/05/2008 | 15/01/2008 | A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD) | A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD) | Metachromatic Leukodystrophy (MLD) in late infantile patients MedDRA version: 9.1;Level: LLT;Classification code 10024381;Term: Leukodystrophy | Product Name: HGT-1111 Product Code: rhASA INN or Proposed INN: Not available Other descriptive name: recombinant human arylsulfatase A | Shire Human Genetic Therapies Inc | NULL | Not Recruiting | Female: yes Male: yes | 0 | Phase 2 | France;Belgium;Denmark;Italy | ||
| 5 | NCT00681811 (ClinicalTrials.gov) | February 2008 | 19/5/2008 | Open-Label Extension Study of Recombinant Human Arylsulfatase A (HGT-1111) in Late Infantile MLD | A Multi-center, Open-Label Extension Study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) Treatment in Patients With Late Infantile Metachromatic Leukodystrophy (MLD) | Late Infantile Metachromatic Leukodystrophy | Drug: HGT-1111 | Shire | NULL | Terminated | 3 Years | 6 Years | All | 11 | Phase 2 | Denmark |
| 6 | NCT00633139 (ClinicalTrials.gov) | August 2007 | 29/2/2008 | Long-term Metazym Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD) | A Single Center, Open-Label, Non-Randomized, Uncontrolled, Multiple-Dose, Dose Escalation Study of the Safety, Pharmacokinetics, Efficacy and Long Term Safety of HGT-1111 (Recombinant Human Arylsulfatase A [rhASA, Metazym]) for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD) | Late Infantile Metachromatic Leukodystrophy | Biological: Recombinant human Arylsulfatase A (rhASA) | Shire | NULL | Completed | 1 Year | 5 Years | All | 13 | Phase 1/Phase 2 | Denmark |