Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214240
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2005-09-13
Brief Title:
The Impact of Cytogam on Time to Viral Load Reduction in Kidney or KidneyPancreas Transplant Recipients With Clinical CMV Disease
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
The Impact of Cytogam on Time to Viral Load Reduction in Kidney or KidneyPancreas Transplant Recipients With Clinical CMV Disease
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
This pilot study is to assess whether using CytoGam in combination with ganciclovir is more effective in reducing the CMV viral load over time as compared to standard treatment with IV ganciclovir only Serial blood samples are drawn to measure the amount of CMV viral load weekly while the subject is receiving treatment with ganciclovir or ganciclovir CytoGam Additional CMV viral load blood sampling CMV DNA capture qualitative testing only will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable whichever is longer duration
Detailed Description:
None
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