Trial Information

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

Status: No longer recruiting

Protocol Number: NV20235

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A double-blind, randomized, placebo controlled, multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in immunocompromised patients.

Brief 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. Target sample size is 470.

Study Phase: IV

Study Design / Study Details:

• Purpose: Prevention
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Influenza

Intervention Type: Drug

Intervention Name: oseltamivir [Tamiflu]

Primary Outcome: 1. Percentage of patients with laboratory-confirmed clinical influenza Time frame: 12 weeks

Key Secondary Outcomes: 1. Percentage of subjects with asymptomatic influenza, percentage with flu-like illness, incidence of secondary illnesses. Time frame: 12 weeks 2. AEs, laboratory parameters, vital signs. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 1 year Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2007

Trial Registration Date: 12/18/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:43:44 PM