A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
NCT ID: NCT00412737
Last Updated: 2016-06-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
477 participants
INTERVENTIONAL
2007-01-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
NCT00412555
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
NCT00436124
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
NCT01050257
A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain
NCT01032837
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants
NCT02717754
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oseltamivir
Oseltamivir
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Placebo
Placebo
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oseltamivir
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Placebo
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).
Exclusion Criteria
* Influenza vaccination in 6 weeks prior to randomization;
* Positive rapid diagnostic test for influenza;
* Solid organ transplant within 6 months of randomization;
* Antiviral treatment for influenza in 2 weeks prior to randomization.
1 Year
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Stanford, California, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Newark, Delaware, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Brooklyn Center, Minnesota, United States
Missoula, Montana, United States
Camden, New Jersey, United States
Hackensack, New Jersey, United States
Livingston, New Jersey, United States
Newark, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Aalst, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Edmonton, Alberta, Canada
Coquitlam, British Columbia, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Brno, , Czechia
Tallinn, , Estonia
Tartu, , Estonia
Paris, , France
Paris, , France
Paris, , France
Toulouse, , France
Tours, , France
Aachen, , Germany
Berlin, , Germany
Hamburg, , Germany
Heidelberg, , Germany
München, , Germany
München, , Germany
Budapest, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Padua, , Italy
Pavia, , Italy
Roma, , Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Bialystok, , Poland
Lodz, , Poland
Szczecin, , Poland
Warsaw, , Poland
Warsaw, , Poland
Madrid, , Spain
Madrid, , Spain
Birmingham, , United Kingdom
Edinburgh, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ison MG, Szakaly P, Shapira MY, Krivan G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NV20235
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.