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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: oseltamivir (Drug); oseltamivir (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Reference Study ID Number: NV20234 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Summary

This 2-arm study will investigate the safety and tolerability of twice daily conventional and double dose Tamiflu (oseltamivir) for the treatment of influenza in immunocompromised patients. Eligible immunocompromised patients with laboratory-confirmed influenza will be randomized to receive either conventional dose (30mg-75mg twice daily po, depending on age and weight) or double 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 medication is 10 days and the anticipated time on study is 40 days.

Clinical Details

Official title: A Double-blind, Randomized, Stratified Multi-center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Safety (incidence of adverse events)

Tissue rejection or graft versus host disease in transplant patients

Development of viral resistance to Tamiflu

Secondary outcome:

Time to alleviation of all clinical influenza symptoms

Proportion of viral shedding

Viral load

Pharmacokinetics: Area under the concentration-time curve (AUC)

Development of secondary illnesses

Eligibility

Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female patients, >=1 year of age

- Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours

prior to first dose

- Immunocompromised patients 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 Exclusion Criteria:

- 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 Tamiflu

- Participation in a study with an investigational drug from 4 weeks prior to study

start until study end

Locations and Contacts

Reference Study ID Number: NV20234 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Buenos Aires 1202, Argentina; Recruiting

Buenos Aires, Argentina; Recruiting

Ciudad Autonoma Buenos Aires 1426, Argentina; Recruiting

Ciudad Autonoma Buenos Aires 1430, Argentina; Recruiting

La Plata 1900, Argentina; Recruiting

Santa Fe S3000CII, Argentina; Recruiting

Aalst 9300, Belgium; Completed

Bruxelles 1000, Belgium; Recruiting

Bruxelles 1070, Belgium; Recruiting

Bruxelles 1090, Belgium; Terminated

Plovdiv 4002, Bulgaria; Terminated

Plovdiv 4002, Bulgaria; Recruiting

Sofia 1431, Bulgaria; Terminated

Sofia 1527, Bulgaria; Terminated

Santiago 8207257, Chile; Not yet recruiting

Santiago 7500539, Chile; Recruiting

Valparaiso 2340000, Chile; Not yet recruiting

Viña del Mar Valparaiso 2520000, Chile; Recruiting

Barranquilla, Colombia; Recruiting

Bogota, Colombia; Recruiting

Cali, Colombia; Recruiting

Floridablanca, Colombia; Recruiting

Brno 625 00, Czech Republic; Terminated

Plzen 300 00, Czech Republic; Terminated

Praha 5 150 06, Czech Republic; Terminated

Praha 12820, Czech Republic; Terminated

Tabor 390 01, Czech Republic; Terminated

Terezin 411 55, Czech Republic; Terminated

Zlin 760 01, Czech Republic; Terminated

Tallinn 10617, Estonia; Recruiting

Tallinn 13419, Estonia; Recruiting

Tartu 51014, Estonia; Recruiting

Tartu 51014, Estonia; Terminated

Lyon 69317, France; Terminated

Paris 75019, France; Terminated

Paris 75475, France; Terminated

Paris 75908, France; Terminated

Toulouse 31059, France; Terminated

Tours 37044, France; Terminated

Aachen 52057, Germany; Terminated

Berlin 13353, Germany; Terminated

Essen 45122, Germany; Terminated

Hamburg 20246, Germany; Terminated

Heidelberg 69120, Germany; Terminated

Muenchen 80336, Germany; Terminated

Muenster 48149, Germany; Recruiting

Ciudad de Guatemala 01001, Guatemala; Recruiting

Ciudad de Guatemala 01009, Guatemala; Recruiting

Guatemala City 1015, Guatemala; Recruiting

Guatemala City, Guatemala; Recruiting

Budapest 1096, Hungary; Recruiting

Debrecen 4032, Hungary; Terminated

Gyor 9024, Hungary; Recruiting

Gyula 5700, Hungary; Terminated

Gyula 5700, Hungary; Recruiting

Pecs 7624, Hungary; Terminated

Szeged 6720, Hungary; Terminated

Szekesfehervar 8000, Hungary; Recruiting

Szolnok 5000, Hungary; Recruiting

Veszprem 8200, Hungary; Terminated

Haifa 31096, Israel; Completed

Jerusalem 91120, Israel; Recruiting

Petach Tikva 49100, Israel; Terminated

Petach Tikva 49100, Israel; Recruiting

Ramat Gan 52662, Israel; Terminated

Tel Aviv 64239, Israel; Terminated

Tel Hashomer 52621, Israel; Recruiting

Riga LV-1002, Latvia; Recruiting

Riga LV-1004, Latvia; Terminated

Kaunas 50009, Lithuania; Terminated

Kaunas 50009, Lithuania; Recruiting

Klaipeda 92288, Lithuania; Recruiting

Siauliai 76231, Lithuania; Recruiting

Vilnius 08661, Lithuania; Terminated

Vilnius 08661, Lithuania; Recruiting

Vilnius 8117, Lithuania; Recruiting

Cuautitlan Izcalli 54769, Mexico; Recruiting

Guadalajara 44280, Mexico; Recruiting

Mexico, Distrito Federal 14000, Mexico; Recruiting

Mexico 03720, Mexico; Recruiting

Mexico 14080, Mexico; Recruiting

Monterrey 64040, Mexico; Recruiting

Zapopan 45116, Mexico; Recruiting

Bialystok 15-540, Poland; Recruiting

Bydgoszcz 85-079, Poland; Terminated

Krakow 31-501, Poland; Terminated

Lodz 90-153, Poland; Recruiting

Szczecin 70-111, Poland; Terminated

Warszawa 02-006, Poland; Terminated

Warszawa 04-730, Poland; Terminated

Wroclaw 50-367, Poland; Terminated

Wroclaw 50-445, Poland; Terminated

Bucharest 022328, Romania; Terminated

Bloemfontein 9301, South Africa; Recruiting

Durban 4001, South Africa; Recruiting

Durban 4001, South Africa; Not yet recruiting

Durban 4092, South Africa; Not yet recruiting

Johannesburg 1983, South Africa; Not yet recruiting

Johannesburg 2113, South Africa; Recruiting

Middelburg 1055, South Africa; Recruiting

Paarl 7626, South Africa; Recruiting

Port Elizabeth 6020, South Africa; Terminated

Pretoria 0002, South Africa; Completed

Pretoria 0084, South Africa; Recruiting

Pretoria 0112, South Africa; Terminated

Soweto 1818, South Africa; Recruiting

Tygerberg; Cape Town 7505, South Africa; Terminated

Van der Bijl 1911, South Africa; Not yet recruiting

Welkom 9460, South Africa; Recruiting

Barcelona 08035, Spain; Terminated

Barcelona 08036, Spain; Terminated

Madrid 28040, Spain; Terminated

Madrid 28040, Spain; Recruiting

Madrid 28041, Spain; Recruiting

Madrid 28046, Spain; Recruiting

Madrid 28046, Spain; Terminated

Zürich 8091, Switzerland; Terminated

Kiev 01135, Ukraine; Terminated

Kiev 04050, Ukraine; Terminated

Lugnansk 91045, Ukraine; Terminated

Zaporozhye 69600, Ukraine; Completed

Bristol BS2 8BJ, United Kingdom; Terminated

Manchester M13 9WL, United Kingdom; Terminated

Nottingham NG5 1PB, United Kingdom; Terminated

Birmingham, Alabama 35233, United States; Terminated

Hospitalet de Llobregat, Barcelona 08907, Spain; Terminated

Beverly Hills, California 90211, United States; Recruiting

Burbank, California 91505, United States; Recruiting

Los Angeles, California 90095, United States; Terminated

Los Angeles, California 90015, United States; Terminated

Sacramento, California 95817, United States; Recruiting

San Francisco, California 94115, United States; Terminated

Aurora, Colorado 80045, United States; Terminated

Trumbull, Connecticut 06611, United States; Terminated

Newark, Delaware 19713, United States; Terminated

Parma, Emilia-Romagna 43100, Italy; Recruiting

Debary, Florida 32713, United States; Terminated

South Miami, Florida 33143, United States; Recruiting

St Petersburg, Florida 33701, United States; Terminated

Tamarac, Florida 33319, United States; Recruiting

Tampa, Florida 33612, United States; Recruiting

Atlanta, Georgia 30322, United States; Terminated

Atlanta, Georgia 30309, United States; Terminated

Augusta, Georgia 30912, United States; Terminated

Chicago, Illinois 60611, United States; Terminated

Chicago, Illinois 60612, United States; Terminated

Chicago, Illinois 60655, United States; Terminated

Santiago de Compostela, La Coruña 15706, Spain; Not yet recruiting

Roma, Lazio 00165, Italy; Not yet recruiting

Roma, Lazio 00168, Italy; Recruiting

Roma, Lazio RM 00149, Italy; Recruiting

Brescia, Lombardia 25126, Italy; Recruiting

Monza, Lombardia 20052, Italy; Recruiting

Pavia, Lombardia 27100, Italy; Recruiting

New Orleans, Louisiana 70112, United States; Terminated

Winnipeg, Manitoba R3E 6518, Canada; Terminated

Baltimore, Maryland 21201, United States; Recruiting

Boston, Massachusetts 02115, United States; Terminated

Springfield, Massachusetts 01107, United States; Recruiting

Ann Arbor, Michigan 48109-0378, United States; Completed

Detroit, Michigan 48201, United States; Terminated

Detroit, Michigan 48202-2689, United States; Terminated

Detroit, Michigan 48210, United States; Recruiting

Lansing, Michigan 48917, United States; Recruiting

St. Louis, Missouri 63110, United States; Terminated

Milano, Molise 20122, Italy; Not yet recruiting

Camden, New Jersey 08103, United States; Terminated

Hackensack, New Jersey 07601, United States; Terminated

New Hyde Park, New York 11042, United States; Recruiting

New York, New York 10029, United States; Terminated

Charlotte, North Carolina 28210, United States; Recruiting

Matthews, North Carolina 28105, United States; Recruiting

Raleigh, North Carolina 27609, United States; Terminated

Winston Salem, North Carolina 27157, United States; Completed

Cincinnati, Ohio 45267, United States; Terminated

Cleveland, Ohio 44195, United States; Terminated

Toledo, Ohio 43606, United States; Terminated

Oklahoma City, Oklahoma 73112-4481, United States; Terminated

Hershey, Pennsylvania 17033, United States; Terminated

Philadelphia, Pennsylvania 19102, United States; Recruiting

Philadelphia, Pennsylvania 19104, United States; Terminated

Philadelphia, Pennsylvania 19104, United States; Recruiting

Pittsburgh, Pennsylvania 15213, United States; Completed

Rio de Janeiro, RJ 21040-360, Brazil; Recruiting

Sao Paulo, SP 01323-020, Brazil; Recruiting

Sao Paulo, SP 04038-002, Brazil; Recruiting

Saskatoon, Saskatchewan S7M 0Z9, Canada; Terminated

Charleston, South Carolina 29425, United States; Not yet recruiting

Dallas, Texas TX 75246, United States; Terminated

Dallas, Texas 75246, United States; Terminated

Dallas, Texas 75390, United States; Completed

Dallas, Texas 75235, United States; Terminated

Houston, Texas 77005, United States; Terminated

Houston, Texas 77030, United States; Terminated

Lubbock, Texas 79430, United States; Terminated

San Antonio, Texas 78229, United States; Terminated

Temple, Texas 76508, United States; Terminated

Salt Lake City, Utah 84132, United States; Terminated

Additional Information

Starting date: February 2008
Last updated: August 17, 2015

Page last updated: August 23, 2015

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