Clinical Trial: Treatment of West Nile Virus With MGAWN1

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

  • The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) [ Time Frame: Study Day 2, 7, 14, 28, and 120 ]

    The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:

    • 0 = No symptoms at all
    • 1 = No significant disability despite symptoms;
    • 2 = Slight disability;
    • 3 = Moderate disability;
    • 4 = Moderately severe disability;
    • 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;
    • 6 = Dead
  • The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event [ Time Frame: 120 days ]
    Includes adverse events considered possibly, probably, or definitely related to study drug


    • Original Primary Outcome: The percentage of subjects treated with MGAWN1 who show improvement in the modified Rankin Scale (MRS) (≥1 improvement in score) [ Time Frame: 14 Days ]

    Current Secondary Outcome:

    • The Number of Participants With a Favorable Neurologic Outcome [ Time Frame: Study Day 2, 7, 14, 28, and 120 ]

      Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is <=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:

      • 0 = No symptoms at all
      • 1 = No significant disability despite symptoms;
      • 2 = Slight disability;
      • 3 = Moderate disability;
      • 4 = Moderately severe disability;
      • 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;
      • 6 = Dead.
    • Mean Modified Rankin Scale Scores [ Time Frame: Study Day 0, 2, 7, 14, 28, and 120 ]

      The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:

      • 0 = No symptoms at all
      • 1 = No significant disability despite symptoms;
      • 2 = Slight disability;
      • 3 = Moderate disability;
      • 4 = Moderately severe disability;
      • 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;
      • 6 = Dead.
    • Time to a >= 1 Point Reduction in the Modified Rankin Scale Score [ Time Frame: Study Day 2, 7, 14, 28, and 120 ]


    Original Secondary Outcome:

    • Percentage of subjects who show improvement (≥1 improvement in score) compared to baseline in the MRS and time to MRS improvement [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Mean MRS scores [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Percent improvement from baseline in the acute SF-12 health status questionnaire score [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Percent improvement compared to baseline in the Beck Depression Index derived from the SF-12 [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Medical Expenditure Prediction derived from the SF-12 [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Percentage and absolute improvement compared to baseline in Glasgow Coma Score (GCS) [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Percentage of subjects with a favorable neurologic outcome (MRS 0−2) and time to a favorable outcome [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Percentage and absolute improvement compared to baseline in Fatigue Severity Scale (FSS) [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Percentage and absolute improvement compared to baseline in the scored neurologic examination [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Incidence and duration of clinical symptoms [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • Time to resolution of all symptoms [ Time Frame: Pre-specified Study Days up to and including 120 Days ]
    • In-hospital, and 28-day and 120-day all-cause mortality [ Time Frame: 120 Days ]
    • Duration of hospitalization [ Time Frame: 120 Days ]
    • Number of admissions to an intensive care unit [ Time Frame: 120 Days ]
    • Disposition (home, rehabilitation, chronic nursing facility) following the initial hospitalization [ Time Frame: 120 Days ]
    • Evaluate the safety and tolerability of MGAWN1 in all subjects as assessed by: Incidence and severity of AEs and SAEs, Laboratory abnormalities, Vital signs, Electrocardiogram (ECG) abnormalities, Physical examination abnormalities [ Time Frame: 120 Days ]
    • Develop a PK model of MGAWN1 in the patient population [ Time Frame: 120 days ]
    • Assess the immunogenicity of MGAWN1 as determined by antibody levels to MGAWN1 [ Time Frame: 120 Days ]


    Information By: MacroGenics

    Dates:
    Date Received: June 24, 2009
    Date Started: May 2009
    Date Completion:
    Last Updated: October 8, 2012
    Last Verified: October 2012