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

NCT ID: NCT01033734

Last Updated: 2016-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

oseltamivir [Tamiflu]

Intervention Type DRUG

5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.

Interventions

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oseltamivir [Tamiflu]

5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* children, 1-12 years of age
* diagnosis of influenza
* duration of influenza symptoms \</=96 hours prior to first dose of study drug

Exclusion Criteria

* evidence of severe hepatic decompensation
* patients taking probenecid within 1 week prior to first dose of study drug
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Los Angeles, California, United States

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Oakland, California, United States

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Aurora, Colorado, United States

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Wilmington, Delaware, United States

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Jacksonville, Florida, United States

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Chicago, Illinois, United States

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South Bend, Indiana, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Duluth, Minnesota, United States

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Omaha, Nebraska, United States

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Morristown, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tyrone, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Petah Tikva, , Israel

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Beirut, , Lebanon

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Countries

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United States Israel Lebanon

References

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Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.

Reference Type DERIVED
PMID: 26042486 (View on PubMed)

Other Identifiers

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NP25139

Identifier Type: -

Identifier Source: org_study_id

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