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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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Tamiflu (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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 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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The steady-state pharmacokinetic parameters AUC0-12 and Cmax\nof oseltamivir and oseltamivir carboxylate.

Secondary outcome:

Other pharmacokinetic parameters, including t½, Tmax, ke, CL/F, V/F, CLm, Clast, and Tlast

Tolerability and safety parameters, including vital signs and neurological assessments

Pharmacodynamic parameters, including results of viral culture and PCR testing and time to resolution of fever

Eligibility

Minimum age: N/A. Maximum age: 12 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- infants

- laboratory confirmed diagnosis of influenza within 96 hours prior to first dose

- influenza symptoms for 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

Locations and Contacts

Antwerpen 2018, Belgium

Brussels 1180, Belgium

Brussels 1200, Belgium

Amiens 80080, France

Bron 69677, France

Lille 5900, France

Paris 75935, France

Rouen 76031, France

Berlin 13353, Germany

Bochum 44792, Germany

Erlangen 91054, Germany

Freiburg 79106, Germany

Hannover 30173, Germany

Tübingen 72076, Germany

Worms 67547, Germany

Haifa 31096, Israel

Holon 58100, Israel

Milan 20122, Italy

Beirut 11-236, Lebanon

Nijmegen 6525 GA, Netherlands

Rotterdam 3015 GJ, Netherlands

Bydgoszcz 85-079, Poland

Bydgoszcz 85-168, Poland

Debica 39-200, Poland

Trzebnica 55-100, Poland

Wrocaw 50-345, Poland

Madrid 28905, Spain

Madrid 28911, Spain

San Sebastian 20014, Spain

Santiago de Compostela 15706, Spain

Tarragona 43007, Spain

Bristol BS2 8AE, United Kingdom

Dumfries DG1 4AP, United Kingdom

London W2 1NY, United Kingdom

Southampton SO16 6YD, United Kingdom

Additional Information

Starting date: January 2011
Last updated: January 3, 2013

Page last updated: August 23, 2015

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