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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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 30, 2009
Last updated: October 19, 2015
Last verified: October 2015
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 first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.

Condition Intervention Phase
Drug: Tamiflu
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • The steady-state pharmacokinetic parameters AUC0-12 and Cmax\nof oseltamivir and oseltamivir carboxylate. [ Time Frame: Until study discontinuation ]

Secondary Outcome Measures:
  • Other pharmacokinetic parameters, including t½, Tmax, ke, CL/F, V/F, CLm, Clast, and Tlast [ Time Frame: Until study discontinuation ]
  • Tolerability and safety parameters, including vital signs and neurological assessments [ Time Frame: Until study discontinuation ]
  • Pharmacodynamic parameters, including results of viral culture and PCR testing and time to resolution of fever [ Time Frame: Until study discontinuation ]

Enrollment: 58
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
infants 3 to <12 months
Drug: Tamiflu
oral repeating dose
Experimental: 2
infants 1 to <3 months of age
Drug: Tamiflu
oral repeating dose
Experimental: 3
infants 0 to 30 days (post natal) of age
Drug: Tamiflu
oral repeating dose


Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00988325

  Show 35 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00988325     History of Changes
Other Study ID Numbers: WP22849  2009-014365-12 
Study First Received: September 30, 2009
Last Updated: October 19, 2015

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 17, 2017