Trial information
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 type: Interventional; Prevention; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
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:
- 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.
Gender: Males or Females
Age limits: Min: 1 year Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2007
Trial registration date: 12/18/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Aalst
- Bruxelles
- Edegem
- Leuven
Estonia
France
Germany
- Aachen
- Heidelberg
- München
Hungary
Israel
- Jerusalem
- Petah Tikva
- Ramat Gan
Italy
Lithuania
Spain
United Kingdom
United States
- Birmingham, AL
- Denver, CO
- Newark, DE
- Chicago, IL
- Detroit, MI
- Brooklyn Center, MN
- Missoula, MT
- Hackensack, NJ
- Cincinnati, OH
- Cleveland, OH
- Philadelphia, PA
- Dallas, TX
- Houston, TX
