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NCT00227370 · ClinicalTrials.gov registry record · Phase 3

Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

A Phase 3 study, sponsored by Duke University.

Completed
Registry status
Phase 3
Development phase
136
Enrollment target

NCT00227370: Completed Phase 3 study, sponsored by Duke University.

NCT00227370 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00227370, a Phase 3 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 3
Development phase
136 participants
Enrollment target

Study Summary

The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.

Primary Outcome

The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.

Interventions

  • OTHER Placebo
  • DRUG valganciclovir

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2003-07
Est. Completion 2008-12
Phase Phase 3
Duke University

1,725 total trials

What the finished NCT00227370 record still lists

NCT00227370 is an interventional study that assigns participants to a tested intervention. The registered 136 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 (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00227370 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00227370 about?

NCT00227370 is a clinical study titled "Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation". The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.

What is the current status of trial NCT00227370?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2003-07. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00227370?

The interventions under investigation include: Placebo (OTHER), valganciclovir (DRUG).

Who is sponsoring clinical trial NCT00227370?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00227370's enrollment target sits among peer trials

136 1580th of 2000 higher than 419 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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Source: ClinicalTrials.gov NCT00227370, the US trial registry maintained by the National Library of Medicine. NCT00227370 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.