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Full notification Final report - General information Notification Number B/DE/22/PEI4755 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 17/12/2021 Title of the Project Clinical Study DTX301-CL301, “A Phase 3 Randomized, Double-Blind, Placebo- Controlled Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Patients with Late-Onset OTC Deficiency” Proposed period of release: 01/10/2021 to 30/09/2022 Name of the Institute(s) or Company(ies) Ultragenyx Pharmaceutical, Inc., 60 Leveroni Ct Novato, CA 94949 USA
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany; Spain; France; United Kingdom; Italy; Netherlands; Portugal;
Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): GMO characterization GMO is a: DNA Virus Identity of the GMO: Genus: Dependoparvovirus Species: Adeno-associated virus serotype 8 (AAV8)  Information relating to the recipient or parental organisms from which the GMO is derived Common Name: N/A Genus: Dependoparvovirus Species: Adeno-associated virus Subspecies: Strain: serotype 8 Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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