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
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 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
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Oseltamivir
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014