Agalsidase Alpha ( DrugBank: Agalsidase alpha )


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT04281537
(ClinicalTrials.gov)
March 1, 20207/2/2020A Study to Describe the Experience of Both Patients and Their Clinicians in the Treatment of Fabry Disease With Enzyme Replacement Therapy.A Multi-country Time and Motion Study to Describe the Experience of Clinicians, Patients and Their Caregivers During the Treatment of Fabry Disease With Enzyme Replacement Therapy With Agalsidase Alfa and Agalsidase BetaFabry DiseaseDrug: Agalsidase Beta;Drug: Agalsidase AlphaAmicus TherapeuticsNULLCompleted18 YearsN/AAll76United States;Brazil;Japan;Taiwan;Turkey
2NCT02956954
(ClinicalTrials.gov)
March 25, 20173/11/2016Follow-up of Myocardial T1 Relaxation Time in Patients With Anderson Fabry DiseaseFollow-up of Myocardial T1 Relaxation Time in Patients With Anderson Fabry Disease (AFD): Impact of Treatment by Agalsidase Alpha (Replagal®)Anderson-Fabry DiseaseDrug: Enzyme replacement therapy (Agalsidase alpha (Replagal®));Procedure: Magnetic Resonance ImagingUniversity Hospital, RouenNULLUnknown status18 YearsN/AAll25N/AFrance
3EUCTR2007-005543-22-SI
(EUCTR)
18/03/201124/02/2011An investigation of 3 dosages of Replagal in adult patients with Fabry diseaseA Multi-center, Open-Label, Randomized Study Evaluating the Safety andEfficacy of Three Dosing Regimens of Replagal Enzyme ReplacementTherapy in Adult Patients with Fabry Disease Fabry Disease
MedDRA version: 14.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Replagal
Product Name: Replagal
INN or Proposed INN: agalsidase alpha
Other descriptive name: Replagal
Shire Human Genetic Therapies, Inc. (Shire HGT)NULLNot RecruitingFemale: yes
Male: yes
43United States;Czech Republic;Slovenia;Paraguay;Finland;Australia;United Kingdom
4EUCTR2007-005543-22-FI
(EUCTR)
18/05/201023/03/2010An investigation of 3 dosages of Replagal in adult patients with Fabry diseaseA Multi-center, Open-Label, Randomized Study Evaluating the Safety andEfficacy of Three Dosing Regimens of Replagal Enzyme ReplacementTherapy in Adult Patients with Fabry Disease Fabry Disease
MedDRA version: 14.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Replagal
Product Name: Replagal
INN or Proposed INN: agalsidase alpha
Other descriptive name: Replagal
Shire Human Genetic Therapies, Inc. (Shire HGT)NULLNot RecruitingFemale: yes
Male: yes
43Phase 3;Phase 4United States;Czech Republic;Slovenia;Paraguay;Finland;Australia;United Kingdom
5EUCTR2007-005543-22-GB
(EUCTR)
06/05/201017/08/2009An investigation of 3 dosages of Replagal in adult patients with Fabry disease A Multi-center, Open-Label, Randomized Study Evaluating the Safety and Efficacy of Three Dosing Regimens of Replagal Enzyme Replacement Therapy in Adult Patients with Fabry Disease Fabry Disease
MedDRA version: 14.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Replagal
Product Name: Replagal
INN or Proposed INN: agalsidase alpha
Other descriptive name: Replagal
Shire Human Genetic Therapies, Inc. (Shire HGT)NULLNot Recruiting Female: yes
Male: yes
43 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Czech Republic;Slovenia;Paraguay;Finland;Australia;United Kingdom
6EUCTR2007-005543-22-CZ
(EUCTR)
19/06/200802/01/2008An investigation of 3 dosages of Replagal in adult patients with Fabry diseaseA Multi-center, Open-Label, Randomized Study Evaluating the Safety andEfficacy of Three Dosing Regimens of Replagal Enzyme ReplacementTherapy in Adult Patients with Fabry Disease Fabry Disease
MedDRA version: 14.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Replagal
Product Name: Replagal
INN or Proposed INN: agalsidase alpha
Other descriptive name: Replagal
Shire Human Genetic Therapies, Inc. (Shire HGT)NULLNot RecruitingFemale: yes
Male: yes
43United States;Czech Republic;Slovenia;Paraguay;Finland;Australia;United Kingdom