Исследования / № 00958776
|Краткое название||A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza|
|Полное название||A Phase 3, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Serious Influenza|
|Под контролем||United States: Food and Drug Administration|
|Краткое описание||A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy|
and safety of peramivir administered intravenously in addition to standard of care compared
to standard of care alone in adults and adolescents who are hospitalized due to serious
|Дата начала||November 2009|
|Вид исследования||Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment|
- Age ?‰?12 years of age, male or female.
- Able to provide informed consent, or for whom consent may be provided by guardian,
unless informed consent provided by a guardian or a legally authorized representative
is not consistent with applicable local or ethical concerns, procedures, directives
- Subject must have at least one of the following clinical presentations at Screening:
1. Oral temperature ?‰? 38.0 ?°C (?‰?100.4 ?°F), ?‰?38.6?°C (?‰?101.4 ?°F) tympanic or rectal
2. Oxygen saturation <92%, OR
3. Two out of the following three vital signs:
Respiration rate >24/minute, Heart rate >100/minute, Systolic BP <90 mmHg
- Presence of at least one respiratory symptom (cough, sore throat, or nasal
congestion) of any severity (mild, moderate, or severe).
- Presence of at least one constitutional symptom (headache, myalgia, feverishness, or
fatigue) of any severity (mild, moderate, or severe).
- Onset of illness no more than 72 hours before presentation. Note: Time of onset of
illness is defined as the earlier of either (1) the time when the temperature was
first measured as elevated, OR (2) the time when the subject experienced the presence
of at least one respiratory symptom AND the presence of at least one constitutional
Severity of illness that, in the Investigator's judgment, justifies hospitalization of the
subject for supportive care.
Presence of one or more of the following factors:
Age ?‰?60 years. Presence of chronic obstructive pulmonary disease (COPD) or other chronic
lung disease requiring daily pharmacotherapy.
Current history of congestive heart failure or angina. Presence of diabetes mellitus,
clinically stable or unstable. Transcutaneous oxygen saturation <94% without supplemental
oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation
from an established baseline value (an investigative site at altitude >2000 ft above sea
level will utilize different criteria for oxygen saturation).
History of chronic renal impairment not requiring peritoneal dialysis. Serum creatinine >
2.0 mg/dL or > 200 ??mol/L.
- Diagnosis of Influenza by satisfying one of the following:
1. Clinical Influenza with Positive Diagnostic Test. Subjects who have a positive
rapid antigen test (RAT) for influenza A and/or influenza B (using a
Sponsor-approved test kit), or positive test (using other methodology) for
influenza A and/or B virus antigen or RNA performed in a clinical laboratory at
the screening/enrollment evaluation are eligible for enrollment.
2. Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a
negative RAT test may be enrolled once the site has been approved by the Sponsor
to enroll such subjects, based on documentation of an outbreak of influenza in
the community. An influenza outbreak may be documented in the catchment area of
the hospital via one of the following methods: 1) local confirmation of
influenza A or B infection in the current influenza season by a) the
institution's local laboratory, or b) the local public health system, or c) the
national public health system, or d) a laboratory of a recognized multinational
influenza surveillance scheme such as the European Influenza Surveillance
Network (EISN); 2) prior enrollment of a RAT positive subject into this study at
the same institution in the current influenza season.
- Subjects who have been hospitalized for greater than 24 hours (not including time
spent in the Emergency Department).
- Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or
oseltamivir in the previous 7 days.
- Blood platelet count of < 20 x 109/L at the time of the screening evaluation.
- Serum bilirubin > 6 mg/dL or > 105 ??mol/L at time of screening evaluation.
- Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation.
- Congestive heart failure of NYHA Class III or Class IV functional status.
- Serum creatinine > 5.0 mg/dL or > 500 ??mol/L at time of screening evaluation.
- Subjects who require peritoneal dialysis.
- Altered neurologic status as defined by a Glasgow Coma Score of ?‰¤ 9, unless medically
- 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 not excluded.
Hormone treatment for cancer is also not excluded.
- 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 therapy (HAART) for at least 6 months.
- Presence of a pre-existing 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 pre-existing illness that, in the opinion of the investigator, would
place the subject at an unreasonably increased risk through participation in this
- Previous treatment with intravenous or intramuscular peramivir.
- 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 evaluation.
- Subjects who, in the judgment of the investigator, will be unlikely to comply with
the requirements of this protocol.
|Минимальный возраст||12 Years|
|Drug||Peramivir 600mg Adults, Peramivir 10mg/kg Adolescents|
|Контакты и расположение|