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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00988325
First received: September 30, 2009
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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
Influenza
Drug: Tamiflu
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other pharmacokinetic parameters, including t½, Tmax, ke, CL/F, V/F, CLm, Clast, and Tlast [ Time Frame: Until study discontinuation ] [ Designated as safety issue: No ]
  • Tolerability and safety parameters, including vital signs and neurological assessments [ Time Frame: Until study discontinuation ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameters, including results of viral culture and PCR testing and time to resolution of fever [ Time Frame: Until study discontinuation ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988325

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00988325     History of Changes
Other Study ID Numbers: WP22849, 2009-014365-12
Study First Received: September 30, 2009
Last Updated: January 3, 2013
Health Authority: European Union: European Medicines Agency
Israel: Ministry of Health
Lebanon: Ministry of Public Health

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014