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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:
ClinicalTrials.gov Identifier:
NCT01053663
First Posted: January 21, 2010
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Influenza Drug: Tamiflu Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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).


Enrollment: 9
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053663


  Show 39 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01053663     History of Changes
Other Study ID Numbers: NP25138
First Submitted: January 20, 2010
First Posted: January 21, 2010
Results First Submitted: January 15, 2016
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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