Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
NCT00227370 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2024-10-04
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.
Conditions
- Cytomegalovirus Infections
Interventions
- DRUG
-
valganciclovir
valgan 900mg QD x 9 months post lung transplant
- OTHER
-
Placebo
Sponsors & Collaborators
-
Roche Pharma AG
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Scott M Palmer, MD · Duke University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-07-31
- Primary Completion
- 2008-04-30
- Completion
- 2008-12-31
Countries
- United States
Study Locations
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