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

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza, Human

In brief

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams \[mg\] to 75 mg twice daily orally \[po\], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

Key facts

Study ID

NCT00545532

Run by

Hoffmann-La Roche

People needed

228

Starts

2008-02-04

Expected to finish

2017-05-02

Last updated by the study team

2018-07-12

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
• Immunocompromised participants with primary or secondary immunodeficiency
• Symptoms suggestive of influenza-like illness
• Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding

You may not qualify if…

• Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization
• Antiviral treatment for influenza in 2 weeks prior to randomization
• Severe hepatic impairment
• Any current renal replacement therapy
• Any gastrointestinal disorders which may interfere with the absorption of oseltamivir
• Participation in a study with an investigational drug from 4 weeks prior to study start until study end

Where it is running

• University of Alabama at Birmingham; Pediatric Nephrology — Birmingham, Alabama, United States
• Pacific Oaks Medical Group — Beverly Hills, California, United States
• Providence Clinical Research — Burbank, California, United States
• AIDS Research Alliance — Los Angeles, California, United States
• UCLA Medical center Medicine/Nephrology — Los Angeles, California, United States
• University of California Davis Health System — Sacramento, California, United States
• CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi — San Francisco, California, United States
• University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan — Aurora, Colorado, United States
• New England Research Associates — Trumbull, Connecticut, United States
• Christiana Care Health System — Newark, Delaware, United States
• Omega Research Consultants — Orlando, Florida, United States
• Kendall South Medical Center Inc. — South Miami, Florida, United States
• All Children'S Hospital; Pediatric Blood & Marrow Transplant Program — St. Petersburg, Florida, United States
• Vita Research Solutions, Inc — Tamarac, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Piedmont Hospital; Transplant Services — Atlanta, Georgia, United States
• EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center — Atlanta, Georgia, United States
• Medical College of Georgia; Medicine/ Nephrology — Augusta, Georgia, United States
• Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine — Chicago, Illinois, United States
• Rush Uni Medical Center; Medicine/ Section of Infectious Diseases — Chicago, Illinois, United States
• University of Chicago; Infectious Disease — Chicago, Illinois, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Brigham & Women'S Hospital — Boston, Massachusetts, United States
• Uni of Alabama At Birmingham; Division of Nephrology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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