AT2220 ( DrugBank: AT2220 )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
256筋型糖原病6

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 133 - (DrugBank : 29) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 105
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2011-002154-32-GB
(EUCTR)
07/12/201107/10/2011Drug-drug interaction study between AT2220 and ERTAN OPEN-LABEL MULTI-CENTER, INTERNATIONAL STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT2220 AND ALGLUCOSIDASE ALFA IN PATIENTS WITH POMPE DISEASE Pompe Disease
MedDRA version: 14.1;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Duvoglustat hydrochloride
Product Code: AT2220
INN or Proposed INN: Duvoglustat hydrochloride
Other descriptive name: 1-deoxynojirimycin hydrochloride
Product Name: Duvoglustat hydrochloride
Product Code: AT2220
INN or Proposed INN: Duvoglustat hydrochloride
Other descriptive name: 1-deoxynojirimycin hydrochloride
Amicus Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
22United States;France;Canada;United Kingdom
2NCT01380743
(ClinicalTrials.gov)
October 31, 201123/6/2011Drug-drug Interaction StudyAn Open-Label, Multi-Center, International Study to Investigate Drug-Drug Interactions Between AT2220 and Alglucosidase Alfa in Patients With Pompe DiseasePompe DiseaseDrug: duvoglustat;Drug: rhGAAAmicus TherapeuticsNULLCompleted18 Years65 YearsAll25Phase 2United States;Canada;France;United Kingdom
3EUCTR2008-002302-18-DE
(EUCTR)
16/02/200926/09/2008An open-label, multicenter, study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of three dosing regimens of oral AT2220 in patients with Pompe disease - Pompe Disease
MedDRA version: 9.1;Level: LLT;Classification code 10036143;Term: Pompe's disease
Product Code: AT2220
Other descriptive name: 1-deoxynojirimycin hydrochloride
Product Code: AT2220
Other descriptive name: 1-deoxynojirimycin hydrochloride
Amicus Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
18United Kingdom;Germany
4EUCTR2008-002302-18-GB
(EUCTR)
18/12/200807/01/2009An open-label, multicenter, study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of three dosing regimens of oral AT2220 in patients with Pompe disease - Pompe Disease
MedDRA version: 9.1;Level: LLT;Classification code 10036143;Term: Pompe's disease
Product Code: AT2220
Other descriptive name: 1-deoxynojirimycin hydrochloride
Product Code: AT2220
Other descriptive name: 1-deoxynojirimycin hydrochloride
Amicus Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
18Germany;United Kingdom
5NCT00688597
(ClinicalTrials.gov)
December 8, 200830/5/2008Study to Evaluate the Safety of AT2220 (Duvoglustat) in Pompe DiseaseAn Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Three Dosing Regimens of Oral AT2220 in Patients With Pompe DiseasePompe DiseaseDrug: DuvoglustatAmicus TherapeuticsNULLTerminated18 Years74 YearsAll3Phase 2United States;Australia;Canada;France;Germany;Netherlands;United Kingdom
6EUCTR2013-002257-30-GB
(EUCTR)
21/10/2013A dose finding study with intravenous administration of duvoglustat hydrochloride (AT2220) and Myozyme in Pompe patientsAN OPEN-LABEL SAFETY AND DOSE-FINDING STUDY OF INTRAVENOUS DUVOGLUSTAT CO-ADMINISTERED WITH RECOMBINANT HUMAN ACID a-GLUCOSIDASE IN SUBJECTS WITH POMPE DISEASE Pompe disease
MedDRA version: 20.0;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: duvoglustat hydrochloride
Product Code: AT2220
INN or Proposed INN: duvoglustat HCl
Trade Name: Myozyme
Product Name: Myozyme
INN or Proposed INN: ALGLUCOSIDASE ALFA
Amicus Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Netherlands;United Kingdom