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

Influenza Clinical Trial

Official title:

A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412737
• Other study ID #: NV20235
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2006
• Last updated: July 30, 2010
• Est. completion date: November 2008

Study information

• Verified date: July 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• oseltamivir [Tamiflu]
30-75mg po daily for 12 weeks
• Placebo
po daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Lithuania,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No. of Patients With Laboratory-confirmed Clinical Influenza		12 weeks	No
Secondary	No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture		12 weeks	No
Secondary	No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)		12 weeks	No
Secondary	No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)		12 weeks	No

External Links

•   Clinical Study Report Synopsis