Roche trials database

Trial information

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

Status:

Active, not recruiting

Protocol number:

NP25139

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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

Brief 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. Target sample size is 7.

Study phase:

I

Study type:

Interventional; Treatment; Non-randomized; Single group; Pharmacokinetics/dynamics study

Conditions:

• Influenza

Intervention type:

Drug

Intervention name:

oseltamivir [Tamiflu]

Primary outcome:

1. Pharmacokinetics: AUC, Cmax, Tmax, CL, V Time frame: multiple sampling Day 1 and Day 3 or 4 if still receiving iv therapy
2. Safety: Adverse events, vital signs, laboratory parameters Time frame: 30 days

Key secondary outcomes:

1. Pharmacodynamics: viral shedding, viral load Time frame: from baseline to Day 30
2. Frequency of resistance to oseltamivir Time frame: from baseline to Day 30

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

Gender:

Males or Females

Age limits:

Min: 1 year Max: 12 years

Accepts healthy volunteers:

No

Anticipated start date:

December, 2010

Trial registration date:

23.10.2009

Date last updated:

06.05.2013

This trial was conducted at the following locations:

Israel

• PETACH TIKVA

Lebanon

• BEIRUT

U.S.A.

• LOS ANGELES, CA
• OAKLAND, CA
• AURORA, CO
• WILMINGTON, DE
• JACKSONVILLE, FL
• CHICAGO, IL
• SOUTH BEND, IN
• WICHITA, KS
• LOUISVILLE, KY
• BOSTON, MA
• SPRINGFIELD, MA
• DETROIT, MI
• DULUTH, MN
• DURHAM, NC
• RALEIGH, NC
• OMAHA, NE
• MORRISTOWN, NJ
• SYRACUSE, NV
• BRONX, NY
• BROOKLYN, NY
• NEW YORK, NY
• STONY BROOK, NY
• AKRON, OH
• CLEVELAND, OH
• DAYTON, OH
• TOLEDO, OH
• OKLAHOMA CITY, OK
• TYRONE, PA
• PROVIDENCE, RI
• CHARLESTON, SC
• HOUSTON, TX
• RICHMOND, VA
• MADISON, WI

Link to trial result