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AVI-4020 Injection

An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (WNV) Disease

Ensayo de Sarepta Therapeutics, Inc. en West Nile Fever (del registro, en inglés).

Fase

Fase 1

Estado

Interrumpido

Participantes

50

previstos

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2004.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to limited pool of eligble WNV patients».

Qué mide

Safety and tolerability assessments will be based on evaluations of treatment emergent adverse events (TEAE), serious adverse events (SAE), serial clinical examinations, and serial conventional laboratory tests. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAlthough the serious form of West Nile Virus (WNV) disease, referred to as neuroinvasive disease, is rare, it can result in permanent disabilities and occasionally death. For patients who get this serious form of WNV disease, there are no approved specific treatment options. The purpose of this study is to test a new drug, AVI-4020 Injection, in patients who are hospitalized with recent symptoms of this form of WNV disease. In this study, we will determine if the AVI-4020 treatment is safe. This will be accomplished by reviewing the results of laboratory tests and clinical signs and symptoms. Additionally, we will review the patient data for signs that AVI-4020 is providing any beneficial effects against WNV neuroinvasive disease.

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Ficha completa en ClinicalTrials.gov (NCT00091845), actualizada en jul 2009.