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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 19, 2014
Last verified: August 2014
  Purpose

This open-label, randomized, adaptive, two-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of Tamiflu (oseltamivir) in immunocomp romised 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 t riple dose of Tamiflu orally daily for a minimum of 5 days and up to 20 days. In fants 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
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, see Learn About Clinical Studies.

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 47 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: August 19, 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 September 18, 2014