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A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

NCT00412737 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2016-06-10

Study results available
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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.

Conditions

Interventions

DRUG

Oseltamivir

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412737 on ClinicalTrials.gov