CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 136 enrolled
Drug / intervention
valganciclovir +1 moredrug
Likely dose
Valganciclovir 900 mg orally once daily for 9 months post-transplantAI-extracted
Key inclusion· 6
  • ✓Adult lung transplant recipients age 18 or older
  • ✓At risk for CMV: donor or recipient serology must be positive for CMV
  • ✓Adequate hematological and renal function
  • ✓On intravenous ganciclovir within 24 hours of surgery
Key exclusion· 8
  • ✕Repeat transplantation
  • ✕Mechanical ventilation at study entry
  • ✕Acute CMV infection or disease
  • ✕Anti-CMV therapy within 30 days before enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00227370
NCT00227370Phase 3Completed
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A Phase III, Randomized, Double-Blind Comparison of Oral Valganciclovir and Placebo for Prevention of CMV After Lung Transplantation

Duke University·interventional·Posted Sep 28, 2005·Updated Oct 4, 2024

In Brief

A Phase 3 clinical trial evaluating valganciclovir and Placebo for Cytomegalovirus Infections. Completed, enrolled 136 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infections
CountriesUnited States
CollaboratorsRoche Pharma AG

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2005
Enrollment StartJul 1, 2003
Primary CompletionApr 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.8 years ago

Interventions

valganciclovirdrug

valgan 900mg QD x 9 months post lung transplant

Placeboother