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A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

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)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

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

Summary

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Clinical Details

Official title: An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection

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

Primary outcome:

Pharmacokinetics: AUC, Cmax, Tmax, CL, V

Safety: Adverse events, vital signs, laboratory parameters

Secondary outcome:

Pharmacodynamics: viral shedding, viral load

Frequency of resistance to oseltamivir

Eligibility

Minimum age: 1 Year. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- children, 1-12 years of age

- diagnosis of influenza

- duration of influenza symptoms Exclusion Criteria:

- evidence of severe hepatic decompensation

- patients taking probenecid within 1 week prior to first dose of study drug

Locations and Contacts

Petach Tikva 19202, Israel

Beirut 11-236, Lebanon

Los Angeles, California 90095, United States

Oakland, California 94609-1809, United States

Aurora, Colorado 80045, United States

Wilmington, Delaware 19803, United States

Jacksonville, Florida 32209, United States

Chicago, Illinois 60611, United States

South Bend, Indiana 46601, United States

Wichita, Kansas 67214, United States

Louisville, Kentucky 40202, United States

Boston, Massachusetts 02118, United States

Boston, Massachusetts 02115, United States

Boston, Massachusetts 02111, United States

Springfield, Massachusetts 01199, United States

Detroit, Michigan 48201, United States

Duluth, Minnesota 55805, United States

Omaha, Nebraska 68131, United States

Syracuse, Nevada 13210, United States

Morristown, New Jersey 07960, United States

Bronx, New York 10461, United States

Brooklyn, New York 11203, United States

New York, New York 10016, United States

Stony Brook, New York 11794-8161, United States

Durham, North Carolina 27705, United States

Raleigh, North Carolina 27610, United States

Akron, Ohio 44308-1062, United States

Cleveland, Ohio 44106-5063, United States

Dayton, Ohio 45404, United States

Toledo, Ohio 43606, United States

Toledo, Ohio 43608, United States

Oklahoma City, Oklahoma 73104, United States

Tyrone, Pennsylvania 16686, United States

Providence, Rhode Island 02903, United States

Charleston, South Carolina 29524, United States

Houston, Texas 77030, United States

Richmond, Virginia 23298, United States

Madison, Wisconsin 53792, United States

Additional Information

Starting date: December 2010
Last updated: May 13, 2013

Page last updated: August 23, 2015

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