Avalglucosidasi alfa ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
256Muscle glycogenosis1

256. Muscle glycogenosis


Clinical trials : 180 Drugs : 133 - (DrugBank : 29) / Drug target genes : 25 - Drug target pathways : 105
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PhaseCountries
1EUCTR2020-004686-39-IT
(EUCTR)
27/04/202107/06/2021Clinical Study for IOPD Participants Less Than or Equal to 6 Months of age to Evaluate Efficacy and Safety of enzyme replacement therapy (ERT) WithAvalglucosidase Alfa(Baby-COMET)An Open-label, Multinational, Multicenter, Intravenous Infusion Study of the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of avalglucosidase alfa inTreatment-naïve Pediatric Participants Less than or Equal to 6 Months of Age with Infantile-Onset Pompe Disease (IOPD) - Baby-COMET Glycogen storage disease type II
MedDRA version: 20.1;Level: PT;Classification code 10053185;Term: Glycogen storage disease type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Avalglucosidase Alfa
Product Code: [GZ402666]
INN or Proposed INN: avalglucosidasi alfa
Other descriptive name: RECOMBINANT HUMAN ALFA-GLUCOSIDASE CONJUGATED WITH SYNTHETIC BISMANNOSE-6-PHOSPHATE-MAN6 GLYCAN
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3France;United States;Taiwan;Belgium;Netherlands;Germany;United Kingdom;China;Italy