A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
Phase 1
Active, not recruiting
- Conditions
- InfluenzaTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-003004-31-Outside-EU/EEA
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
children, 1-12 years of age
diagnosis of influenza
duration of influenza symptoms Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
evidence of severe hepatic decompensation
patients taking probenecid within 1 week prior to first dose of studydrug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective was to define the pharmacokinetics of oseltamivir and OC and evaluate the safety profile following IV administration of OP in children between 1 and 12 years of age with influenza. ;Secondary Objective: The secondary objectives were as follows: to evaluate viral load and shedding and to evaluate all isolates for phenotypic and, where necessary, genotypic resistance ;Primary end point(s): Pharmacokinetics: AUC, Cmax, Tmax, CL, V<br>Safety: Adverse events, vital signs, laboratory parameters ;Timepoint(s) of evaluation of this end point: Pharmacokinetics: AUC, Cmax, Tmax, CL, V [Time Frame: multiple sampling Day 1 and Day 3 or 4 if still receiving iv therapy]<br>Safety: Adverse events, vital signs, laboratory parameters [Time Frame: 30 days]
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pharmacodynamics: viral shedding, viral load<br>Frequency of resistance to oseltamivir ;Timepoint(s) of evaluation of this end point: Pharmacodynamics: viral shedding, viral load [ Time Frame: from baseline to Day 30 ]<br>Frequency of resistance to oseltamivir [ Time Frame: from baseline to Day 30 ]