Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02635724 | Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza | PHASE3 | COMPLETED | 74 | — | — | Dec 1, 2015 | Sep 1, 2018 | Mar 23, 2021 | 15 | United States |
| NCT02369159 | Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza | PHASE3 | COMPLETED | 137 | — | — | Mar 11, 2015 | May 14, 2020 | Mar 23, 2021 | 10 | United States, South Africa |
| NCT02665351 | Peramivir Treatment Response in Adults Hospitalized for Influenza-associated Lower Respiratory Tract Infections | PHASE2 | COMPLETED | 16 | — | — | Feb 1, 2011 | Mar 1, 2014 | Jan 29, 2016 | 1 | China |
| NCT00453999 | Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza | PHASE2 | COMPLETED | 137 | — | — | Jul 1, 2007 | Aug 1, 2009 | Feb 12, 2015 | 83 | United States, Australia +5 |
| NCT00419263 | Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza. | PHASE2 | COMPLETED | 344 | — | — | Jan 1, 2007 | Sep 1, 2007 | Feb 12, 2015 | 69 | United States, Canada |
Safety was evaluated through assessment of Adverse Events (AEs).
Safety evaluation included assessment of Adverse Events (AEs).
5-10 days
Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).
Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.
| Arm | Type | Description |
|---|---|---|
| Peramivir | EXPERIMENTAL | Single dose 600 mg IV injection |
| Peramivir (IV) | EXPERIMENTAL | Subjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes. * Subjects ≥12 years will receive a dose of 600 mg. * Subjects \<12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg). * Subjects \< 6 months will receive a dose of 8 mg/kg. |
| Oseltamivir | ACTIVE_COMPARATOR | Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days. * Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days). * Subjects \< 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days). |
| Peramivir 300mg Q12H | ACTIVE_COMPARATOR | Peramivir 300 mg, administered intravenously, twice daily (every 12 hours) |
| Peramivir 600mg Q24H | ACTIVE_COMPARATOR | Peramivir 600 mg, administered intravenously, once daily (every 24 hrs) |
| Arm 1: Peramivir 200 mg | EXPERIMENTAL | Peramivir 200 mg administered intravenously once daily for 5 days (5 doses) |
| Arm 2: Peramivir 400 mg | EXPERIMENTAL | Peramivir 400 mg administered intravenously once daily for 5 days (5 doses) |
| Arm 3: Oseltamivir | EXPERIMENTAL | Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses) |
| Peramivir 150 mg | EXPERIMENTAL | - |
| Peramivir 300 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Peramivir | DRUG | - |
| Oseltamivir | DRUG | - |
| Peramivir 200 mg | DRUG | Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment |
| Peramivir 400 mg | DRUG | Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml) |
| Peramivir 150 mg | DRUG | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). |
| Peramivir 300 mg | DRUG | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). |
| Placebo | DRUG | Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo). |
Inclusion Criteria: * A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR * Clinical signs and symptoms consistent with acute influenza infection consisting of an oral tem...