Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497796
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2007-07-05
Brief Title:
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus CMV Disease in Liver Transplant Recipients
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-blind Study To Assess The Efficacy And Safety Of Prophylactic Use Of Maribavir Versus Oral Ganciclovir For The Prevention Of Cytomegalovirus Disease In Recipients Of Orthotopic Liver Transplants
Status:
COMPLETED
Status Verified Date:
2021-06
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 this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant
Detailed Description:
Cytomegalovirus CMV infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 14 weeks following orthotopic liver transplantation
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 |
|---|---|---|---|
| SHP620-301 | OTHER | Shire | None |
| 2007-004729-16 | EUDRACT_NUMBER | None | None |