Status:
COMPLETED
A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Influenza
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE1
Brief Summary
This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir \[Tamiflu\] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the firs...
Eligibility Criteria
Inclusion
- infants \</=12 months of age
- laboratory confirmed diagnosis of influenza within 96 hours prior to first dose
- influenza symptoms for \</=96 hours prior to first dose
Exclusion
- preterm infants less than 40 weeks (corrected for gestational age)
- weight less than 5th percentile for age (corrected for gestational age)
- concurrent gastrointestinal conditions that preclude enteric absorption of the drug
- bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrollment
- active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease at baseline
- symptomatic inborn errors of metabolism
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00988325
Start Date
January 1 2011
End Date
April 1 2012
Last Update
March 20 2017
Active Locations (12)
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1
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
2
Hôpital Femme Mère Enfant; Service de rhumatologie pédiatrique
Bron, France, 69677
3
CAMPUS VIRCHOW-KLINIKUM CharitéCentrum 17 Klinik f.Pädiatrie Abt.Pneumologie u.Immunologie
Berlin, Germany, 13353
4
LWL-Klinik-Bochum
Bochum, Germany, 44792