19. ライソゾーム病 Lysosomal storage disease Clinical trials / Disease details
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 | EUCTR2004-002743-27-IT (EUCTR) | 26/07/2005 | 10/08/2005 | An open-label extension of study TKT024 evaluating long-term safety and clinical outcomes in MPS II patients receiving iduronate-2-sulfatase enzyme replacement therapy. | An open-label extension of study TKT024 evaluating long-term safety and clinical outcomes in MPS II patients receiving iduronate-2-sulfatase enzyme replacement therapy. | Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome) MedDRA version: 6.1;Level: PT;Classification code 10056889 | Product Name: Idursulfase Product Code: I2S | TKT INC | NULL | Not Recruiting | Female: no Male: yes | 94 | United Kingdom;Germany;Spain;Italy;Sweden | |||
| 2 | EUCTR2004-002743-27-SE (EUCTR) | 11/05/2005 | 17/03/2005 | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome) MedDRA version: 6.1;Level: PT;Classification code 10056889 | Product Name: Idursulfase (I2S) Other descriptive name: Idursulfase | Shire Human Genetic Therapies INC. | NULL | Not Recruiting | Female: no Male: yes | 96 | United Kingdom;Germany;Spain;Italy;Sweden | |||
| 3 | EUCTR2004-002743-27-ES (EUCTR) | 21/04/2005 | 04/04/2006 | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome) MedDRA version: 6.1;Level: PT;Classification code 10056889 | Product Name: Idursulfase (I2S) Other descriptive name: Idursulfase | TKT Inc. | NULL | Not Recruiting | Female: no Male: yes | 94 | Phase 3 | Spain;Germany;Italy;United Kingdom;Sweden | ||
| 4 | EUCTR2004-002743-27-GB (EUCTR) | 31/01/2005 | 23/02/2005 | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome) MedDRA version: 6.1;Level: PT;Classification code 10056889 | Product Name: Idursulfase (I2S) Other descriptive name: Idursulfase | TKT Inc. | NULL | Not Recruiting | Female: no Male: yes | 94 | Phase 3 | Spain;Germany;Italy;United Kingdom;Sweden | ||
| 5 | EUCTR2004-002743-27-DE (EUCTR) | 23/12/2004 | 30/11/2004 | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome) MedDRA version: 6.1;Level: PT;Classification code 10056889 | Product Name: Idursulfase (I2S) Other descriptive name: Idursulfase | Shire Human Genetic Therapies INC. | NULL | Not Recruiting | Female: no Male: yes | 96 | United Kingdom;Germany;Spain;Italy;Sweden | |||
| 6 | NCT00630747 (ClinicalTrials.gov) | September 2004 | 28/2/2008 | Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase | An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | Hunter Syndrome;Mucopolysaccharidosis II (MPS II) | Biological: Idursulfase | Shire | NULL | Completed | 5 Years | N/A | Male | 94 | Phase 2/Phase 3 | United States;Brazil;Canada;France;Germany;Italy;Romania;Spain;Sweden;United Kingdom |
| 7 | NCT00069641 (ClinicalTrials.gov) | September 2003 | 29/9/2003 | Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II) | A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Weekly and Every Other Week Dosing Regimens of Iduronate-2-Sulfatase Enzyme Replacement Therapy in Patients With MPS II | Mucopolysaccharidosis II | Biological: Iduronate-2-sulfatase enzyme replacement therapy;Biological: iduronate-2-sulfatase enzyme replacement therapy;Biological: Placebo | Shire | NULL | Completed | 5 Years | 25 Years | Male | 96 | Phase 2/Phase 3 | United Kingdom;Brazil;Germany;United States |