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 symptomsSafety: 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
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