Table of Studies

Indonesia SEA001 Announcement

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Dear SEA ICRN Colleagues,

Enrollment in SEA 001 in Indonesia has been temporarily interrupted while some specific data management issues are addressed.  We are hopeful of a quick resolution and resumption of screening and enrollment in the near future and will keep the all apprised.

 Sincerely,

 Steve Wignall

Network Chief Operations Officer

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Study Summary

Design: Phase II double-blind, randomized, multi-center, international clinical trial, designed to assess safety andefficacy of standard- and high-dose oseltamivir in patients hospitalized with severe influenza or avian influenza.

Population: 600 subjects (male and female):

• 300 subjects meeting criteria for severe influenza
• 300 subjects meeting criteria for avian influenza

A maximum of 200 subjects will be enrolled in any one age range:

•  1-<15 yrs
• 15 yrs

Study Duration: 4 years or after 300 subjects in the severe influenza group are enrolled, whichever occurs first.

Primary Objective: To compare the antiviral efficacy of standard-dose and high-dose oseltamivir in the treatment of severe human influenza infections as assessed by negative RT-PCR for viral RNA in nose and throat swabs at Day 5.

Primary Endpoint: The percentage of subjects with severe influenza that have no viral shedding at day 5 as assessed by negative RT-PCR for viral RNA in nose and throat swabs.

Study Sites: Thailand, Vietnam, Indonesia and the US.