An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu) in the treatment of infants 0 to < 12 months of age with confirmed influenza infection. - ND

• Register: EUCTR
• Last refreshed on: 28 August 2012
• Main ID: EUCTR2009-014365-12-IT
• Date of registration: 13/01/2010
• Prospective Registration: No
• Primary sponsor: F.Hoffmann-La Roche
• Public title: An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu) in the treatment of infants 0 to < 12 months of age with confirmed influenza infection. - ND
• Scientific title: An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu) in the treatment of infants 0 to < 12 months of age with confirmed influenza infection. - ND
• Date of first enrolment: 15/12/2009
• Target sample size: 85
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014365-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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...


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of influenza.
MedDRA version: 9.1 Level: LLT Classification code 10022000

Intervention(s)

Trade Name: Tamiflu
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Oseltamivir
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Main Objective: To define the pharmacokinetics of oseltamivir and oseltamivir carboxylate in children with confirmed influenza up to one year of age.

Primary end point(s): The primary variables are the steady-state pharmacokinetic parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate.

Secondary Objective: -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).

Secondary ID(s)

2009-014365-12-ES

WP22849