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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00545532
The ClinicalTrials.gov registry entry for NCT00545532 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 16,211-participant average among 18 other Influenza, Human trials with a reported enrollment target (99% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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