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
Overview
- Phase
- Phase 3
- Intervention
- Peramivir+SOC
- Conditions
- Cough
- Sponsor
- BioCryst Pharmaceuticals
- Enrollment
- 405
- Locations
- 40
- Primary Endpoint
- Time to Clinical Resolution (Kaplan-Meier Estimate)
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 and/or guidelines.
- •Subject must have at least one of the following clinical presentations at Screening:
- •Oral temperature ≥ 38.0 °C (≥100.4 °F), ≥38.6°C (≥101.4 °F) tympanic or rectal OR
- •Oxygen saturation \<92%, OR
- •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 symptom.
Exclusion Criteria
- •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 μmol/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 μmol/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 induced.
- •Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or breastfeeding.
Arms & Interventions
Peramivir+SOC
* Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. * Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Intervention: Peramivir+SOC
Placebo+SOC
Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Intervention: Placebo+SOC
Outcomes
Primary Outcomes
Time to Clinical Resolution (Kaplan-Meier Estimate)
Time Frame: 10 days
Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).
Secondary Outcomes
- Change (Reduction) in Influenza Virus Titer(Baseline and 24, 48, 108 hours)
- Time to Alleviation of Clinical Symptoms of Influenza(10 days)
- Time to Resolution of Fever (Kaplan-Meier Estimate)(10 days)
- Time to Resumption of Usual Activities(10 days)
- Number of Subjects With ICU Admission(10 days)
- Duration of All ICU Admissions (Kaplan-Meier Estimate)(10 days)