A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

Phase 1

Completed

• Conditions: Influenza
• Interventions: Drug: oseltamivir [Tamiflu]

• Registration Number: NCT01033734
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2016-01-15
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-13
• Last Update Submitted: 2016-07-13
• Results First Posted: 2016-08-24
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• children, 1-12 years of age
• diagnosis of influenza
• duration of influenza symptoms </=96 hours prior to first dose of study drug

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Exclusion Criteria

• evidence of severe hepatic decompensation
• patients taking probenecid within 1 week prior to first dose of study drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	oseltamivir [Tamiflu]	-

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2	Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5	Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3	Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2	Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5	Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3	Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4	Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4	Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

Secondary Outcome Measures

Name	Time	Method
Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values	Baseline, Day 1, 6 and 30	IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either \>=5 times change in the NAI IC50 visit value from the Reference value at a visit, \>=5 times change in the NAI IC50 Visit value from the Baseline value.
Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate	Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion