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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00412737

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 IV

MedlinePlus related topics: Flu

Drug Information available for: Oseltamivir Tamiflu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo Controlled, Multi-Center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients with laboratory-confirmed clinical influenza [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects with asymptomatic influenza, percentage with flu-like illness, incidence of secondary illnesses. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	470
Study Start Date:	January 2007
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Experimental	Drug: oseltamivir [Tamiflu] 30-75mg po daily for 12 weeks
2: Placebo Comparator	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 80 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV20235
Study First Received:	December 15, 2006
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00412737 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human

Orthomyxoviridae Infections
Antiviral Agents
Oseltamivir

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Orthomyxoviridae Infections
Antiviral Agents
Pharmacologic Actions

Oseltamivir
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Influenza, Human

ClinicalTrials.gov processed this record on May 07, 2009