CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 477 enrolled
Drug / intervention
Oseltamivir +1 moredrug
Likely dose
Oseltamivir 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00412737
NCT00412737Phase 4Completed

A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients

Hoffmann-La Roche·interventional·Posted Dec 18, 2006·Updated Jun 10, 2016

In Brief

A Phase 4 clinical trial evaluating Oseltamivir and Placebo for Influenza. Completed, enrolled 477 participants across 78 sites in 14 countries.

Detailed Summary

This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBelgium, Canada, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Lithuania, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2006
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.5 years ago

Interventions

Oseltamivirdrug

Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.

Placebodrug

Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.