E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Uncomplicated acute influenza |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of peramivir administered intramuscularly; To evaluate secondary clinical outcomes in response to treatment; To evaluate changes in influenza virus titer (viral shedding) in response to treatment; To assess pharmacoeconomic measures in response to treatment; To assess changes in influenza viral susceptibility to neuraminidase inhibitors following treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and non-pregnant female subjects age ≥18 years 2. A Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab. A negative initial RAT may be repeated within one hour of obtaining a negative result. 3. Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. For subjects with a positive RAT at the time of screening, a subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at time of screening. For subjects with no positive RAT at screening, fever as defined above must be documented at time of screening 4. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe) 5. Presence of at least one constitutional symptom (myalgia [muscle aches], headache, feverishness, or fatigue) of any severity (mild, moderate, or severe) 6. Onset of symptoms no more than 48 hours before presentation for screening 7. Written informed consent
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E.4 | Principal exclusion criteria |
1. Women who are pregnant or breast-feeding 2. Presence of clinically significant signs of acute respiratory distress 3. History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma 4. History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class IV functional status within the past 12 months 5. History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min) 6. Current clinical evidence of active bacterial infection at any body site that requires therapy with oral or systemic antibiotics 7. Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy 8. Current treatment for active viral hepatitis C 9. Presence of known HIV infection with a CD4 count <350 cell/mm3 10. Current therapy with oral warfarin or other systemic anticoagulant 11. Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening 12. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days 13. History of alcohol abuse or drug addiction within 1 year prior to admission in the study 14. Participation in a previous study of peramivir as treatment for acute influenza or previous participation in this study 15. Participation in a study of any investigational drug within the last 30 days
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical: Time to alleviation of clinical symptoms of influenza
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 191 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |