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A Pharmacokinetic/Pharmacodynamic Study of Tamiflu (Oseltamivir) in Immunocompromised Children With Confirmed Influenza Infection

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 [Tamiflu] (Drug); oseltamivir [Tamiflu] (Drug)

Phase: Phase 1

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: NV25719 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Summary

This open-label, randomized, adaptive, two-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of Tamiflu (oseltamivir) in immunocompromised children, 2 weeks to less than 13 years of age, with confirmed influenza infection. Patients will be randomized to receive either the standard dose or triple dose of Tamiflu orally daily for a minimum of 5 days and up to 20 days. Infants less than 1 year of age will be randomized to the standard dose arm only.

Clinical Details

Official title: AN OPEN-LABEL, RANDOMIZED, ADAPTIVE, TWO-ARM, MULTICENTER TRIAL TO EVALUATE PHARMACOKINETICS AND PHARMACODYNAMICS OF TWO DOSES OF OSELTAMIVIR (TAMIFLU®) IN THE TREATMENT OF INFLUENZA IN IMMUNOCOMPROMISED CHILDREN, FROM 2 WEEKS TO LESS THAN 13 YEARS OF AGE, WITH CONFIRMED INFLUENZA INFECTION

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Pharmacodynamics: Time to cessation of viral shedding

Secondary outcome:

Time to resolution of influenza symptoms

Safety: Incidence of adverse events

Safety: Incidence of influenza associated complications

Frequency of viral resistance

Eligibility

Minimum age: N/A. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female children, < 13 years of age

- Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral

culture positive for influenza

- Immunocompromised

- Symptoms/signs suggestive of influenza like illness (ILI)

- Less than or equal to 96 hours between onset of ILI and first dose of study drug

Exclusion Criteria:

- Clinical evidence of severe hepatic impairment

- Infants < 2 weeks of age or, if born pre-term, with post-menstrual age (PMA) < 36

weeks

- Clinical evidence of renal impairment

- Allergy to oseltamivir or excipients

- Hereditary fructose intolerance

- Received anti-viral treatment with activity against influenza (e. g. amantadine,

rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization

Locations and Contacts

Reference Study ID Number: NV25719 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Brussel 1090, Belgium; Recruiting

Bruxelles 1200, Belgium; Recruiting

Leuven 3000, Belgium; Recruiting

Santiago 7500539, Chile; Not yet recruiting

Viña del Mar 2520000, Chile; Recruiting

Cali, Colombia; Recruiting

Turku 20520, Finland; Terminated

Berlin 13353, Germany; Recruiting

Frankfurt 60590, Germany; Recruiting

Münster 48149, Germany; Recruiting

Tübingen 72076, Germany; Recruiting

Guatemala Zona 11, Guatemala; Not yet recruiting

Haifa 31096, Israel; Terminated

Jerusalem 9112001, Israel; Recruiting

Petach Tikva 49100, Israel; Recruiting

Ramat-Gan 52621, Israel; Recruiting

Tel Aviv 64239, Israel; Recruiting

Mexico 04530, Mexico; Not yet recruiting

Monterrey 64460, Mexico; Not yet recruiting

Gdansk 80-214, Poland; Recruiting

Olsztyn 10-561, Poland; Terminated

Szczecin 71-242, Poland; Recruiting

Zabrze 41-800, Poland; Recruiting

Cape Town 7500, South Africa; Completed

Johannesburg 1501, South Africa; Recruiting

Johannesburg 2013, South Africa; Recruiting

Barcelona 08035, Spain; Recruiting

Madrid 28007, Spain; Recruiting

Madrid 28009, Spain; Recruiting

Esplugues De Llobregas, Barcelona 08950, Spain; Completed

Aurora, Colorado 80045, United States; Recruiting

Roma, Lazio 00165, Italy; Recruiting

Milano, Lombardia 20122, Italy; Recruiting

Monza, Lombardia 20052, Italy; Recruiting

Boston, Massachusetts 02111, United States; Recruiting

Syracuse, New York 13210, United States; Recruiting

Ottawa, Ontario K1H 8L1, Canada; Recruiting

Toronto, Ontario M5G 1X8, Canada; Recruiting

Curitiba, PR 81520-060, Brazil; Not yet recruiting

Montreal, Quebec H3H 1P3, Canada; Recruiting

Porto Alegre, RS 90610-000, Brazil; Recruiting

Sao Paulo, SP 04023-062, Brazil; Not yet recruiting

São Paulo, SP 08270-070, Brazil; Recruiting

Seattle, Washington 98105, United States; Recruiting

Additional Information

Starting date: January 2014
Last updated: August 17, 2015

Page last updated: August 23, 2015

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