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A Pharmacokinetic/Pharmacodynamic Study of Tamiflu (Oseltamivir) in Immunocompromised Children With Confirmed Influenza Infection

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715909
First received: October 25, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This open-label, randomized, adaptive, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of Tamiflu (oseltamivir) in immunocompromised children 0-18 years of age with confirmed influenza infection. Patients will be randomized to receive either the standard dose, double dose or triple dose of Tamiflu orally daily for a minimum of 5 days and up to 20 days.


Condition Intervention Phase
Influenza
 Drug: oseltamivir [Tamiflu]
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AN OPEN LABEL, RANDOMISED, ADAPTIVE, MULTICENTER, PHARMACOKINETIC/PHARMACODYNAMIC, PHASE IB, STUDY OF OSELTAMIVIR (TAMIFLU®) IN THE TREATMENT OF INFLUENZA IN IMMUNOCOMPROMISED CHILDREN, BETWEEN 0-18 YEARS OF AGE, WITH CONFIRMED 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:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Time to cessation of viral shedding [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to resolution of influenza symptoms [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of influenza associated complications [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Frequency of viral resistance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard dose Drug: oseltamivir [Tamiflu]
standard dose orally daily, 5-20 days
Experimental: Double dose Drug: oseltamivir [Tamiflu]
double standard dose orally daily, 5-20 days
Experimental: Triple dose Drug: oseltamivir [Tamiflu]
triple standard dose orally daily, 5-20 days

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female children, <18 years of age
  • Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
  • Immunocompromised
  • Symptoms/signs suggestive of influenza like illness (ILI)
  • Less than or equal to 96 hours between onset of ILI and first dose of study drug

Exclusion Criteria:

  • Clinical evidence of severe hepatic impairment
  • Infants who were born pre-term with post-menstrual age (PMA) < 36 weeks
  • Clinical evidence of renal impairment
  • Allergy to oseltamivir or excipients
  • Hereditary fructose intolerance
  • Received anti-viral treatment with activity against influenza (e.g. amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715909

Contacts
Contact: Please reference Study ID Number: NV25719 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 30 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: NCT01715909     History of Changes
Other Study ID Numbers: NV25719, 2012-002633-11
Study First Received: October 25, 2012
Last Updated: May 7, 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 19, 2013