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

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ClinicalTrials.gov Identifier: NCT01053663
Recruitment Status : Terminated (The study was terminated prematurely after three influenza seasons.)
First Posted : January 21, 2010
Results First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 20, 2010
First Posted Date  ICMJE January 21, 2010
Results First Submitted Date  ICMJE January 15, 2016
Results First Posted Date  ICMJE July 27, 2016
Last Update Posted Date July 27, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • 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 ]
  • 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 ]
  • AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4 [ Time Frame: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ]
  • 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 ]
  • 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 ]
  • Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4 [ Time Frame: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2010)
  • 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 ]
Change History Complete list of historical versions of study NCT01053663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
    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 ]
    Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Influenza
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Tamiflu
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 16, 2016)
9
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2010)
36
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 365 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01053663
Other Study ID Numbers  ICMJE NP25138
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2016

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