Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227370
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2005-09-26
Brief Title:
Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus CMV After Lung Transplantation
Sponsor:
Scott Palmer
Organization:
Duke University
Study Overview
Official Title:
A Phase III Randomized Double-Blind Comparison of Oral Valganciclovir and Placebo for Prevention of CMV After Lung Transplantation
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Valgan
Brief 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
Detailed Description:
A multi-center two phase double-blind placebo controlled randomized prospective study of 130 lung transplant recipients Patients will be screened and consented prior to transplant All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days Patients will enroll in Phase I of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for CMV After completion of 3 months of open label therapy patients that meet the criteria for Phase II of the study will be randomized to 9 months of blinded therapy PlaceboValgan Phase II of the study is designed to assess the efficacy of short course sequential IV ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of CMV disease in at risk lung transplant recipients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4623 Val038 | OTHER | Alternative study ID | None |