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

• Register: EUCTR
• Last refreshed on: 28 August 2012
• Main ID: EUCTR2009-014365-12-FR
• Date of registration: 15/10/2009
• Prospective Registration: Yes
• 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
• 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
• Date of first enrolment: 11/01/2010
• Target sample size: 85
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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: Open: Single blind: Double blind: Parallel group: Cross over: Other: 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
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:
- Post conceptual age less than 36 weeks
- Weight less than 5th percentile for age (corrected for gestation)
- concurrent gastrointestinal conditions that preclude enteric absorption of the drug
- bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrolment
- Have evidence of active or uncontrolled respiratory, cardiac, hepatic, CNS or renal
disease unrelated to influenza at baseline
- Non-study treatment with Oseltamivir for the current illness prior to first study
dose


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

Health Condition(s) or Problem(s) studied

Treatment of influenza
MedDRA version: 12.0 Level: LLT Classification code 10022000 Term: Influenza

Intervention(s)

Trade Name: Tamiflu
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: oseltamivir
CAS Number: 204255-11-8
Current Sponsor code: Ro 64-0796
Other descriptive name: OSELTAMIVIR PHOSPHATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12-

Primary Outcome(s)

Secondary Objective: The secondary objectives are:
• 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)

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

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

Secondary ID(s)

WP22849

2009-014365-12-ES