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 Un estudio para evaluar la seguridad y eficacia de Dexametasona más MLN9708 o el tratamiento elegido por el médico en pacientes con amiloidosis recidivante o refractaria. non-technical, languageĪ study to assess the safety and efficacy of dexamethasone plus MLN9708 or physician choice of treatment in patients with relapsed or refractory amyloidosis. 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 3 Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) AmyloidosisĮstudio de fase 3, aleatorizado, controlado, abierto, multicéntrico para evaluar la seguridad y la eficacia de Dexametasona más MLN9708 en comparación con el tratamiento elegido por el médico administrado a pacientes con amiloidosis sistémica de cadenas ligeras recidivante o refractaria 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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