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

This study has been terminated.
(The study was terminated prematurely after three influenza seasons.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01053663
First received: January 20, 2010
Last updated: June 16, 2016
Last verified: June 2016

January 20, 2010
June 16, 2016
January 2011
January 2013   (final data collection date for primary outcome measure)
  • 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: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
  • AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2 [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2 ] [ Designated as safety issue: No ]
  • AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4 [ Time Frame: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1 [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
  • Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2 [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2 ] [ Designated as safety issue: No ]
  • Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4 [ Time Frame: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ] [ Designated as safety issue: No ]
  • Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate [ Time Frame: Multiple sampling day 3 or 4 ] [ Designated as safety issue: No ]
  • Safety Profile: AEs, vital signs, laboratory parameters [ Time Frame: Days 1-11 and on follow up days 15 and 30 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01053663 on ClinicalTrials.gov Archive Site
  • Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ] [ Designated as safety issue: No ]
  • Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ] [ Designated as safety issue: No ]
  • Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ] [ Designated as safety issue: No ]
  • Number of Participants With Greater Than or Equal to (≥) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values [ Time Frame: Baseline, Days 1, 3, 4, 6, 15 ] [ Designated as safety issue: No ]
    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 or ≥5 times change in the NAI IC50 Visit value from the Baseline value.
  • Number of Participants With Oseltamivir Resistance Mutation [ Time Frame: Up to Day 30 ] [ Designated as safety issue: No ]
    Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
  • Viral load and shedding [ Time Frame: Assessment days 1, 3 or 4, 6, 11, and optional at days 15 and 30 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
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
This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days. Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Influenza
Drug: Tamiflu
10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6
Experimental: 1
Intervention: Drug: Tamiflu
Muñoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infant patients
  • Date of birth to date of enrollment is <1 year
  • Diagnosis of influenza
  • Duration of influenza symptoms </=96 hours prior to first dose
  • - Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)

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
Both
up to 365 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT01053663
NP25138
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP