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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988325
• Other study ID #: WP22849
• Secondary ID: 2009-014365-12
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2009
• Last updated: October 19, 2015
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyIsrael: Ministry of HealthLebanon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Influenza

Intervention

Drug:
• Tamiflu
oral repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Israel,  Italy,  Lebanon,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The steady-state pharmacokinetic parameters AUC0-12 and Cmax\nof oseltamivir and oseltamivir carboxylate.		Until study discontinuation	No
Secondary	Other pharmacokinetic parameters, including t½, Tmax, ke, CL/F, V/F, CLm, Clast, and Tlast		Until study discontinuation	No
Secondary	Tolerability and safety parameters, including vital signs and neurological assessments		Until study discontinuation	No
Secondary	Pharmacodynamic parameters, including results of viral culture and PCR testing and time to resolution of fever		Until study discontinuation	No