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 compared to placebo when administered intramuscularly on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza A. |
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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 positive Influenza A Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer’s instructions. A negative initial RAT should be repeated within one hour. Subjects with a positive influenza B or mixed A and B RAT will be excluded. 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. 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 the time of Screening. 4. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity. 5. Presence of at least one constitutional symptom (myalgia [muscle aches], headache, feverishness, or fatigue) of at least moderate severity. 6. Onset of symptoms no more than 48 hours before presentation for screening. 7. Females of child-bearing potential must have a negative urine pregnancy test at screening/ baseline and utilize approved contraceptive methods. Males enrolled must ensure that their female partners of childbearing potential utilize approved contraceptive methods to avoid pregnancy. 8. 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 III or 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. Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza. 7. Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics. 8. Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening. 9. Currently receiving treatment for viral hepatitis B or viral hepatitis C. 10. Presence of known HIV infection with a CD4 count <350 cell/mm3. 11. Current therapy with oral warfarin or other systemic anticoagulant. 12. Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening. 13. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days. 14. Immunized against influenza with inactivated virus vaccine within the previous 14 days. 15. Receipt of any intramuscular injection within the previous 14 days. 16. History of alcohol abuse or drug addiction within 1 year prior to admission in the study 17. Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study. 18. Participation in a study of any investigational drug or device 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 in subjects with influenza A. |
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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 | Yes |
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 | 8 |
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 |