Trials / Terminated
TerminatedNCT00927953
Treatment of West Nile Virus With MGAWN1
Phase 2, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MGAWN1 in Subjects With Laboratory-documented West Nile Fever or Suspected Central Nervous System Infection Due to West Nile Virus
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will test a drug called MGAWN1 for the treatment of West Nile infections.
Detailed description
The objective of this study is to evaluate the safety, efficacy, and pharmacokinetics of MGAWN1 in subjects with West Nile Fever or a syndrome compatible with West Nile Neuroinvasive Disease (WNND) \[encephalitis, meningitis, or acute flaccid paralysis\]. Subjects can be enrolled based on a syndrome compatible with WNND, and do not need documented West Nile virus infection.
Conditions
- West Nile Neuroinvasive Disease
- West Nile Virus Infection
- Encephalitis
- Meningitis
- Acute Flaccid Paralysis
- West Nile Fever
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MGAWN1 | Humanized monoclonal to West Nile virus. Dose = 30 mg/kg actual body weight intravenous, one dose at Day 0. |
| BIOLOGICAL | Placebo - normal saline | Normal Saline intravenous, volume same as active comparator, one dose at Day 0 |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2011-02-01
- Completion
- 2011-05-01
- First posted
- 2009-06-25
- Last updated
- 2022-02-10
- Results posted
- 2012-11-07
Source: ClinicalTrials.gov record NCT00927953. Inclusion in this directory is not an endorsement.