Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091845
Status:
TERMINATED
Last Update Posted:
2009-07-08
First Post:
2004-09-17
Brief Title:
An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus WNV Disease
Sponsor:
Sarepta Therapeutics Inc
Organization:
Sarepta Therapeutics Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to limited pool of eligble WNV patients
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
1 To evaluate the safety of intravenously administered IV AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance
2 To evaluate the tolerability of intravenously administered AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance
3 To evaluate the effectiveness of intravenously administered AVI-4020 Injection at 45 mg every 12 hours for ten doses based on the neurological status of each study Subject as measured by a combination of the NIH stroke scale score and the Glasgow coma scale score
4 To evaluate the robustness of the potential effectiveness of intravenously administered AVI-4020 Injection every 12 hours for ten doses over the course of 35 days of active surveillance based on a variety of criteria eg clinical laboratory andor neurophysiological results
2 To evaluate the tolerability of intravenously administered AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance
3 To evaluate the effectiveness of intravenously administered AVI-4020 Injection at 45 mg every 12 hours for ten doses based on the neurological status of each study Subject as measured by a combination of the NIH stroke scale score and the Glasgow coma scale score
4 To evaluate the robustness of the potential effectiveness of intravenously administered AVI-4020 Injection every 12 hours for ten doses over the course of 35 days of active surveillance based on a variety of criteria eg clinical laboratory andor neurophysiological results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None