Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza

Exclusion Criteria

• •Subjects who have been hospitalized for greater than 24 hours (not including time spent in the emergency department).Blood platelet count of \< 20 x 109/L.
• •Serum bilirubin \> 6 mg/dL at time of Screening evaluation.
• •Serum ALT or AST \> 5 X upper limit of normal at time of Screening evaluation.
• •Serum creatinine \> 5.0 mg/dL at time of Screening evaluation.
• •Subjects who require peritoneal dialysis or hemofiltration.
• •Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
• •Females who are pregnant (positive urine or serum pregnancy test at Screening evaluation) or breastfeeding.
• •Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed to enroll in the study. Hormone treatment for cancer is also acceptable).
• •Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
• •HIV infection with a known CD4 count \< 200 cells/ mm3 unless on a stable highly active antiretroviral (HAART) regimen for at least 6 months.
• •Presence of a preexisting chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or C not requiring treatment are not excluded).
• •Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
• •Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the Screening evaluation.
• •Subjects diagnosed with cystic fibrosis.
• •Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of Screening.