![]() The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)Īctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e. IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Trial is part of a Paediatric Investigation PlanĮMA Decision number of Paediatric Investigation Plan non-technical, languageĪ Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subjects with Autosomal Recessive Stargardt DiseaseĮnsayo Clínico para evaluar la seguridad y la eficacia de la administración intravítrea de Zimura en sujetos con enfermedad de Stargardt autosómica recesiva ![]() Title of the trial for lay people, in easily understood, i.e. Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (seeĪ Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects with Autosomal Recessive Stargardt DiseaseĮstudio de fase IIb, aleatorizado, doble ciego y controlado para establecer la seguridad y la eficacia de Zimura™ (inhibidor del C5 del complemento) en comparación con un tratamiento simulado en pacientes con enfermedad de Stargardt autosómica recesiva Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old. Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). Allows you to search for protocol and results information on:
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