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Tracking Information | |
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First Received Date † | September 17, 2004 |
Last Updated Date | August 15, 2007 |
Start Date † | November 2004 |
Current Primary Outcome Measures † |
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. |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00091845 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
A secondary endpoint is the potential effectiveness of AVI-4020 Injection based on the neurological status measured by a combination of the NIH Stroke Scale and the Glasgow Coma Score (GCS). |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (WNV) Disease |
Official Title † | An Exploratory Study of the Safety, Tolerability, Pharmacokinetics and Potential Effectiveness of AVI-4020 Injection in Patients Presenting With Presumptive Acute Neuroinvasive West Nile Virus (WNV) Disease |
Brief Summary | Although 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. |
Detailed Description |
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Study Phase | Phase I |
Study Type † | Interventional |
Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition † | West Nile Fever |
Intervention † | Drug: AVI-4020 Injection |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Terminated |
Estimated Enrollment † | 50 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 75 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00091845 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | AVI BioPharma, Inc. |
Collaborators †† | |
Investigators † | |
Information Provided By | AVI BioPharma, Inc. |
Verification Date | August 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |