Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01053663
First received: January 20, 2010
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: January 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   up to 365 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053663

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01053663     History of Changes
Other Study ID Numbers: NP25138
Study First Received: January 20, 2010
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013