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A Study of Tamiflu (Oseltamivir) for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412737
First received: December 15, 2006
Last updated: July 30, 2010
Last verified: July 2010
History of Changes
  Purpose

This 2 arm study will evaluate the efficacy and safety of Tamiflu in the seasonal prophylaxis of influenza in immunocompromised patients (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive Tamiflu syrup or capsules 30mg-75mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Influenza
 Drug: oseltamivir [Tamiflu]
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

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:
  • No. of Patients With Laboratory-confirmed Clinical Influenza [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 477
Study Completion Date: November 2008
Arms Assigned Interventions
Experimental: 1 Drug: oseltamivir [Tamiflu]
30-75mg po daily for 12 weeks
Placebo Comparator: 2 Drug: Placebo
po daily for 12 weeks

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males or females >=1 year of age;
  • negative rapid diagnostic test for influenza at baseline;
  • immunocompromised subject (liver and/or kidney recipient or allogenic HSCT).

Exclusion Criteria:

  • symptoms suggestive of influenza-like illness;
  • influenza vaccination in 6 weeks prior to randomization;
  • positive rapid diagnostic test for influenza;
  • SOT within 6 months of randomization;
  • antiviral treatment for influenza in 2 weeks prior to randomization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412737

  Show 78 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Clinical Study Report Synopsis  This link exits the ClinicalTrials.gov site

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412737     History of Changes
Other Study ID Numbers: NV20235
Study First Received: December 15, 2006
Results First Received: August 3, 2009
Last Updated: July 30, 2010
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 21, 2013