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

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-002743-27-IT
(EUCTR)
26/07/200510/08/2005An 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 INCNULLNot RecruitingFemale: no
Male: yes
94United Kingdom;Germany;Spain;Italy;Sweden
2EUCTR2004-002743-27-SE
(EUCTR)
11/05/200517/03/2005An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement TherapyAn 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.NULLNot RecruitingFemale: no
Male: yes
96United Kingdom;Germany;Spain;Italy;Sweden
3EUCTR2004-002743-27-ES
(EUCTR)
21/04/200504/04/2006An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement TherapyAn 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.NULLNot RecruitingFemale: no
Male: yes
94Phase 3Spain;Germany;Italy;United Kingdom;Sweden
4EUCTR2004-002743-27-GB
(EUCTR)
31/01/200523/02/2005An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement TherapyAn 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.NULLNot RecruitingFemale: no
Male: yes
94Phase 3Spain;Germany;Italy;United Kingdom;Sweden
5EUCTR2004-002743-27-DE
(EUCTR)
23/12/200430/11/2004An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement TherapyAn 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.NULLNot RecruitingFemale: no
Male: yes
96United Kingdom;Germany;Spain;Italy;Sweden
6NCT00630747
(ClinicalTrials.gov)
September 200428/2/2008Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving IdursulfaseAn Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement TherapyHunter Syndrome;Mucopolysaccharidosis II (MPS II)Biological: IdursulfaseShireNULLCompleted5 YearsN/AMale94Phase 2/Phase 3United States;Brazil;Canada;France;Germany;Italy;Romania;Spain;Sweden;United Kingdom
7NCT00069641
(ClinicalTrials.gov)
September 200329/9/2003Iduronate-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 IIMucopolysaccharidosis IIBiological: Iduronate-2-sulfatase enzyme replacement therapy;Biological: iduronate-2-sulfatase enzyme replacement therapy;Biological: PlaceboShireNULLCompleted5 Years25 YearsMale96Phase 2/Phase 3United Kingdom;Brazil;Germany;United States