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NCT00545532 · ClinicalTrials.gov registry record · Phase 3
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
A Phase 3 study of Influenza, Human, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
- 20
- Study locations
NCT00545532: Completed Phase 3 study of Influenza, Human, sponsored by Hoffmann-La Roche.
NCT00545532 is a Phase 3 study of Influenza, Human that has completed, run by Hoffmann-La Roche. The registered enrollment target is 228 participants, below the 16,211-participant average among 18 other Influenza, Human trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00545532, a Phase 3 study of Influenza, Human, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams \[mg\] to 75 mg twice daily orally \[po\], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.
Primary Outcome
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which wo
Conditions Studied
Interventions
- OTHER placebo
- DRUG oseltamivir
Study Locations (20)
California
- Pacific Oaks Medical Group - Beverly Hills
- Providence Clinical Research - Burbank
- AIDS Research Alliance - Los Angeles
- UCLA Medical center Medicine/Nephrology - Los Angeles
- University of California Davis Health System - Sacramento
- CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi - San Francisco
Florida
- Omega Research Consultants - Orlando
- Kendall South Medical Center Inc. - South Miami
- All Children'S Hospital; Pediatric Blood & Marrow Transplant Program - St. Petersburg
- Vita Research Solutions, Inc - Tamarac
- University of South Florida - Tampa
Georgia
- Piedmont Hospital; Transplant Services - Atlanta
- EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center - Atlanta
- Medical College of Georgia; Medicine/ Nephrology - Augusta
Alabama
- Uni of Alabama At Birmingham; Division of Nephrology - Birmingham
- University of Alabama at Birmingham; Pediatric Nephrology - Birmingham
Colorado
- University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan - Aurora
Connecticut
- New England Research Associates - Trumbull
Delaware
- Christiana Care Health System - Newark
Illinois
- Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2008-02-04 |
| Est. Completion | 2017-05-02 |
| Phase | Phase 3 |
What the finished NCT00545532 record still lists
NCT00545532 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 16,211-participant average among 18 other Influenza, Human trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00545532 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00545532 about?
NCT00545532 is a clinical study titled "A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.". This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised part...
What is the current status of trial NCT00545532?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2008-02-04. Estimated completion is 2017-05-02.
What conditions does trial NCT00545532 study?
This clinical trial studies the following conditions: Influenza, Human.
What interventions are being tested in trial NCT00545532?
The interventions under investigation include: placebo (OTHER), oseltamivir (DRUG).
Who is sponsoring clinical trial NCT00545532?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00545532 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza, Human
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00545532's enrollment target sits among peer trials
228 14th of 18 higher than 5 of 18 other Influenza, Human trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza, Human trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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