Trial information

A Study of Tamiflu (Oseltamivir) for Treatment of Influenza in Immunocompromised Patients.

Status: Recruiting

Protocol number: NV20234

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, double-blind trial evaluating conventional and high dose Tamiflu in the treatment of influenza in immunocompromised patients

Brief summary: This 2 arm study will investigate the efficacy and safety of twice daily conventional and high dose Tamiflu for the treatment of immunocompromised patients (as represented by transplant recipients). Eligible transplant recipients suffering from symptoms of an influenza-like illness will be randomized to receive either conventional dose (30mg-75mg twice daily po, depending on age and weight) or high dose (60mg-150mg twice daily po depending on age and weight) Tamiflu for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 250.

Study phase: IV

Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study

Condition: Influenza

Intervention type: Drug

Intervention name: oseltamivir [Tamiflu]

Primary outcome: 1. Time to alleviation of all clinical influenza symptoms Time frame: Event driven

Key secondary outcomes: 1. Virus shedding and viral load Time frame: Days 1, 2, 6, 8, 11, 15 and 40 2. Time to resolution of fever Time frame: Event driven 3. Development of secondary illnesses, antibiotic use and hospitalizations. Time frame: Event driven 4. AEs, lab parameters, vital signs. Time frame: Throughout study

Inclusion criteria:

• male and female patients, >=1 year of age;
• rapid diagnostic test positive for influenza in 24h prior to first dose;
• immunocompromised patients (liver and/or kidney transplant recipient, or allogenic HSCT);
• receiving immunosuppressant treatment, or not immune reconstituted;
• symptoms suggestive of influenza-like illness.

Exclusion criteria:

• influenza vaccination in 2 weeks prior to randomization;
• antiviral treatment for influenza in 2 weeks prior to randomization;
• >48h between illness onset and first dose of study drug;
• SOT other than liver and/or kidney.

Gender: Males or Females

Age limits: Min: 1 year Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: February, 2008

Trial registration date: 10/15/2007

Date last updated: 9/29/2008

Link to trial result

This trial is being conducted at the following locations:

Belgium

• Aalst
• Bruxelles
• Leuven

Bulgaria

• Plovdiv
• Sofia

Canada

• Winnipeg, MB
• Saskatoon, SK

Czech Republic

• Brno
• Plzen
• Praha

Estonia

• Tallinn
• Tartu

France

• Paris
• Toulouse
• Tours

Germany

• Aachen
• Berlin
• Essen
• Hamburg
• Heidelberg
• München

Greece

• Athens

Hungary

• Budapest
• Pecs
• Szeged

Israel

• Haifa
• Jerusalem
• Petah Tikva
• Ramat Gan
• Tel Aviv

Italy

• Padova
• Pavia
• Roma

Lithuania

• Kaunas
• Vilnius

Poland

• Bialystok
• Lodz
• Szczecin
• Warszawa
• Wroclaw

Romania

• Bucharest

Spain

• Barcelona
• Madrid

Switzerland

• Zürich

Ukraine

• Kiev
• Lugnansk
• Zaporozhye

United Kingdom

• Nottingham

United States

• Birmingham, AL
• Little Rock, AR
• Los Angeles, CA
• San Francisco, CA
• Denver, CO
• Newark, DE
• St Petersburg, FL
• Atlanta, GA
• Augusta, GA
• Chicago, IL
• New Orleans, LA
• Boston, MA
• Springfield, MA
• Detroit, MI
• Camden, NJ
• Hackensack, NJ
• New York, NY
• Winston-Salem, NC
• Cincinnati, OH
• Cleveland, OH
• Oklahoma City, OK
• Portland, OR
• Hershey, PA
• Philadelphia, PA
• Pittsburgh, PA
• Dallas, TX
• Houston, TX
• Lubbock, TX
• San Antonio, TX
• Temple, TX
• Salt Lake City, UT