E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022000 |
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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 define the pharmacokinetics of oseltamivir and oseltamivir carboxylate in children with confirmed influenza up to one year of age. |
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E.2.2 | Secondary objectives of the trial |
-To describe the frequency of all adverse events among treated children; -To assess the clearance of virus and viral RNA; -To determine the potential for the development of resistance to oseltamivir; -To explore other pharmacodynamic parameters (e.g. resolution of fever). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Post natal* age: Cohort I: 3 to < 12 months, Cohort II: 1 to <3 months, Cohort III: 0 to 30 days. * Post natal age = date of birth to date of enrolment; 2. Confirmed laboratory diagnosis of influenza by PCR or rapid influenza diagnostic test within 96 hours prior to first dose; 3. Duration of influenza symptoms ≤ 96 hours prior to first dose. |
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E.4 | Principal exclusion criteria |
1.Post conceptual* age less than 36 weeks. *Post conceptual age = Gestational age + post natal age Gestational age = date of conception to date of birth (date of conception is usually two weeks after last menstrual period); 2.Participation in an investigational drug or device study within 30 days prior to screening; 3.Requiring inotropic support or vasopressors at the time of enrollment; 4.Concurrent gastrointenstinal conditions that preclude enteric absorption of the drug (eg. protracted vomiting, malabsorption, history of necrotizing enterocolitis with short gut); 5. Bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at the time of enrollment; 6.Subjects with diminished ventilatory reserve at risk for hypercapnia (eg. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, history of surgery for diaphragmatic hernia); 7.Left to right shunt requiring therapy; 8.Renal failure including renal anomalies likely to be associated with renal dysfunction (e.g. clinical conditions of renal dysplasia, polycystic renal disease, renal agenesis); 9.Clinical evidence for hepatic decompensation (liver disease with coagulopathy, encephalopathy); 10.Cerebral palsy with microcephaly, feeding difficulties or seizures; 11.Infants symptomatic due to inborn errors of metabolism (e.g. glycogen storage disorders); 12.Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinemia, immunosuppressive therapy); 13.Have evidence of active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease unrelated to influenza at baseline; 14.Allergy to test medication; 15. Subjects with hereditary fructose intolerance; Et al... |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variables are the steady-state pharmacokinetic parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
- Studio prospettico - Studio di valutazione farmacocinetica/farmacodinamica e di sicurezza |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | No |
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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La fine dello studio e` definita come la data dell`ultima visita dell`ultimo soggetto nello studio. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |