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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT01033734
Date of registration:	15/12/2009
Prospective Registration:	Yes
Primary sponsor:	Hoffmann-La Roche
Public title:	A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
Scientific title:	An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection
Date of first enrolment:	December 2010
Target sample size:	8
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01033734
Study type:	Interventional
Study design:
Phase:	Phase 1

Countries of recruitment
Israel	Lebanon	United States

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- children, 1-12 years of age

- diagnosis of influenza

- duration of influenza symptoms
Exclusion Criteria:

- evidence of severe hepatic decompensation

- patients taking probenecid within 1 week prior to first dose of study drug

Age minimum: 1 Year
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Drug: oseltamivir [Tamiflu]

Primary Outcome(s)

AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5 [Time Frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion]

Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4 [Time Frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion]

AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3 [Time Frame: 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 [Time Frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion]

AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2 [Time Frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion]

Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2 [Time Frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion]

Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5 [Time Frame: 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 [Time Frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion]

Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1 [Time Frame: 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 [Time Frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion]

Secondary Outcome(s)

Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate [Time Frame: 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 of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate [Time Frame: 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 [Time Frame: Baseline, Day 1, 6 and 30]

Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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]

Secondary ID(s)

NP25139

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	24/08/2016
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01033734

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