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

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715909
First received: October 25, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This open-label, randomized, adaptive, two-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of Tamiflu (oseltamivir) in immunocompromised children, 2 weeks to less than 13 years of age, with confirmed influenza infection. Patients will be randomized to receive either the standard dose or triple dose of Tamiflu orally daily for a minimum of 5 days and up to 20 days. Infants less than 1 year of age will be randomized to the standard dose arm only.


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, RANDOMIZED, ADAPTIVE, TWO-ARM, MULTICENTER TRIAL TO EVALUATE PHARMACOKINETICS AND PHARMACODYNAMICS OF TWO DOSES OF OSELTAMIVIR (TAMIFLU®) IN THE TREATMENT OF INFLUENZA IN IMMUNOCOMPROMISED CHILDREN, FROM 2 WEEKS TO LESS THAN 13 YEARS OF AGE, WITH CONFIRMED INFLUENZA INFECTION

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Time to cessation of viral shedding [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to resolution of influenza symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of influenza associated complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Frequency of viral resistance [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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: Triple dose Drug: oseltamivir [Tamiflu]
triple standard dose orally daily, 5-20 days

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female children, < 13 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 < 2 weeks of age or, if 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: Reference Study ID Number: NV25719 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 46 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: April 14, 2014
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 April 15, 2014