A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

• Register: EUCTR
• Last refreshed on: 16 August 2016
• Main ID: EUCTR2016-003003-54-Outside-EU/EEA
• Date of registration: 09/08/2016
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche AG
• Public title: A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
• Scientific title: An Open-label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir in the Treatment of Infants Less Than One Year of Age With Influenza Infection
• Target sample size: 36
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003003-54
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Israel, Lebanon, United States

Contacts

• Name: Roche Trial Information Hotline
• Affiliation: Hoffmann-La Roche

• Name: Roche Trial Information Hotline
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion criteria:
Infant patients
Date of birth to date of enrollment is <1 year
Diagnosis of influenza
Duration of influenza symptoms Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)
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:
Date of conception to date of birth + date of birth to enrollment is <36 weeks
Creatinine clearance <30 mL/min/1.73m2
Patients receiving any form of renal replacement therapy at baseline
Clinical evidence of severe hepatic decompensation at the time of enrollment
Patients taking probenecid medication within 1 week prior to study day 1 or during the study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Influenza

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: Tamiflu

Product Name: Oseltamivir
Pharmaceutical Form: Injection

Trade Name: Tamiflu

Product Name: Oseltamivir
Pharmaceutical Form: Oral suspension

Primary Outcome(s)

Secondary Objective: The secondary objectives of this study were as follows: To evaluate viral load and shedding, To evaluate all isolates for phenotypic and, where necessary, genotypic resistance

Primary end point(s): Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate
Safety Profile: AEs, vital signs, laboratory parameters

Main Objective: The primary objective of this study was to define the pharmacokinetics of oseltamivir and oseltamivir carboxylate (OC) and evaluate the safety profile following IV administration of oseltamivir phosphate (OP) in infants less than 1 year of age with influenza

Timepoint(s) of evaluation of this end point: Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate [Time Frame: Multiple sampling day 3 or 4 ]
Safety Profile: AEs, vital signs, laboratory parameters [ Time Frame: Days 1-11 and on follow up days 15 and 30 ]

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Viral load and shedding [ Time Frame: Assessment days 1, 3 or 4, 6, 11, and optional at days 15 and 30 ]
Development of resistance to oseltamivir [ Time Frame: Assessment days 1, 3 or 4, 6, 11, and at days 15 and 30 if samples are collected]

Secondary end point(s): Viral load and shedding
Development of resistance to oseltamivir

Secondary ID(s)

NCT01053663

NP25138

Source(s) of Monetary Support

Hoffmann-La Roche