Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577363
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
A Survey of Maribavir Tablets in Participants with Cytomegalovirus Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Special Drug Use Surveillance of LIVTENCITY Tablets 200mg All-Case Investigation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus CMV infection refractory to existing anti-CMV therapy in organ transplantation including hematopoietic stem cell transplantation
The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection and to check side effect from the study treatment The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study
During the study participants with CMV infection will take Maribavir tablets according to their clinics standard practice The study doctors will check for side effects from Maribavir tablets for 27 weeks
The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection and to check side effect from the study treatment The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study
During the study participants with CMV infection will take Maribavir tablets according to their clinics standard practice The study doctors will check for side effects from Maribavir tablets for 27 weeks
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