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NCT00411645 · ClinicalTrials.gov registry record · Phase 3
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
A Phase 3 study of Cytomegalovirus Infections, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 681
- Enrollment target
- 20
- Study locations
NCT00411645: Completed Phase 3 study of Cytomegalovirus Infections, sponsored by Shire.
NCT00411645 is a Phase 3 study of Cytomegalovirus Infections that has completed, run by Shire. The registered enrollment target is 681 participants, above the 174-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (291% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00411645, a Phase 3 study of Cytomegalovirus Infections, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 681 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Primary Outcome
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or
Conditions Studied
Interventions
- OTHER placebo
- DRUG maribavir
Study Locations (20)
California
- City of Hope Medical Center - Duarte
- Scripps Green Hospital - La Jolla
- UCSD Moores Center - La Jolla
- UCLA Medical Center - Los Angeles
- University of California, San Francisco - San Francisco
- Stanford University Medical Center - Stanford
Illinois
- Northwestern University Medical Center - Chicago
- University of Chicago - Chicago
- Loyola University - Maywood
Florida
- Shands Hospital - Gainesville
- H. Lee Moffitt Cancer Center - Tampa
Kentucky
- University of Kentucky Chandler Medical Center - Lexington
- University Medical Center University of Louisville Hospital - Louisville
Arkansas
- University of Arkansas Myeloma Institute - Little Rock
Colorado
- Rocky Mountain Cancer Center - Denver
Georgia
- Emory University - Atlanta
Indiana
- St Francis Hospital - Beech Grove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 681 participants |
| Start Date | 2006-12-13 |
| Est. Completion | 2009-05-23 |
| Phase | Phase 3 |
What the finished NCT00411645 record still lists
NCT00411645 is an interventional study that assigns participants to a tested intervention. The registered 681 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (291% higher).
The record links to 1 condition, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00411645 names 20 study sites across 11 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT00411645 about?
NCT00411645 is a clinical study titled "Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients". The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
What is the current status of trial NCT00411645?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 681 participants. The study started on 2006-12-13. Estimated completion is 2009-05-23.
What conditions does trial NCT00411645 study?
This clinical trial studies the following conditions: Cytomegalovirus Infections.
What interventions are being tested in trial NCT00411645?
The interventions under investigation include: placebo (OTHER), maribavir (DRUG).
Who is sponsoring clinical trial NCT00411645?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00411645 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cytomegalovirus Infections
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 NCT00411645's enrollment target sits among peer trials
681 3rd of 24 higher than 22 of 24 other Cytomegalovirus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cytomegalovirus Infections 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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