337. ホモシスチン尿症 Homocystinuria Clinical trials / Disease details
臨床試験数 : 13 / 薬物数 : 13 - (DrugBank : 4) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 23
| 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 | EUCTR2006-000614-21-AT (EUCTR) | 09/08/2007 | 16/06/2006 | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | homocystinuria MedDRA version: 8.1;Level: pref;Classification code 10020365 | Product Name: Prefolic INN or Proposed INN: 5-MTHF Other descriptive name: IUPAC name: 2-[4-[(2-amino-5-methyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl)methylam ino]benzoyl]amino | Zambon Group S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 22 | Hungary;United Kingdom;Italy;Austria | |||
| 2 | EUCTR2006-000614-21-IT (EUCTR) | 11/12/2006 | 05/10/2007 | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria - ND | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria - ND | Homocystinuria MedDRA version: 6.1;Level: PT;Classification code 10020365 | Trade Name: PREFOLIC 15*30CPR GASTROR 15MG INN or Proposed INN: Detoxifying agents for antineoplastic treatment | ZAMBON GROUP | NULL | Not Recruiting | Female: yes Male: yes | 22 | Hungary;United Kingdom;Italy;Austria | |||
| 3 | EUCTR2006-000614-21-HU (EUCTR) | 13/11/2006 | 15/08/2006 | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | homocystinuria MedDRA version: 8.1;Level: pref;Classification code 10020365 | Product Name: Prefolic INN or Proposed INN: 5-MTHF Other descriptive name: IUPAC name: 2-[4-[(2-amino-5-methyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl)methylam ino]benzoyl]amino | Zambon Group S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 2 | Hungary;Slovakia;Austria;United Kingdom | ||
| 4 | EUCTR2006-000614-21-GB (EUCTR) | 13/10/2006 | 20/09/2006 | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | homocystinuria MedDRA version: 8.1;Level: pref;Classification code 10020365 | Trade Name: Prefolic INN or Proposed INN: 5-MTHF Other descriptive name: IUPAC name: 2-[4-[(2-amino-5-methyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl)methylam ino]benzoyl]amino | Zambon Group S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 22 | Hungary;United Kingdom;Italy;Austria | |||
| 5 | EUCTR2006-000614-21-SK (EUCTR) | 20/09/2006 | 12/07/2006 | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria | homocystinuria MedDRA version: 8.1;Level: pref;Classification code 10020365 | Product Name: Prefolic INN or Proposed INN: 5-MTHF Other descriptive name: IUPAC name: 2-[4-[(2-amino-5-methyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl)methylam ino]benzoyl]amino | Zambon Group S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 2 | Hungary;Slovakia;Austria;United Kingdom |