Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-31 @ 4:14 AM
Study NCT ID:
NCT01509404
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2012-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection
Status:
COMPLETED
Status Verified Date:
2018-09
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:
None
Brief Summary:
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: