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NCT00497796 · ClinicalTrials.gov registry record · Phase 3
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 307
- Enrollment target
NCT00497796: Completed Phase 3 study, sponsored by Shire.
NCT00497796 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 307 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00497796, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 307 participants
- Enrollment target
Study Summary
The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.
Primary Outcome
All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic 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 CMV DNA polymerase chain reaction \[PCR\] assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at leas
Interventions
- DRUG ganciclovir
- DRUG maribavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2007-07-23 |
| Est. Completion | 2009-09-14 |
| Phase | Phase 3 |
What the finished NCT00497796 record still lists
NCT00497796 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which ganciclovir is the first listed.
NCT00497796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00497796 about?
NCT00497796 is a clinical study titled "Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients". The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.
What is the current status of trial NCT00497796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 307 participants. The study started on 2007-07-23. Estimated completion is 2009-09-14.
What interventions are being tested in trial NCT00497796?
The interventions under investigation include: ganciclovir (DRUG), maribavir (DRUG).
Who is sponsoring clinical trial NCT00497796?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00497796's enrollment target sits among peer trials
307 1115th of 2000 higher than 886 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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