Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439342
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-28
Brief Title:
A Study of Maribavir in Chinese Adults With Cytomegalovirus CMV Infections
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Open-label Single-arm Study to Evaluate the Safety Tolerability Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus CMV Infections That Are Refractory or Resistant to Treatment With Ganciclovir Valganciclovir Cidofovir or Foscarnet
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 main aim of this study is to learn how safe maribavir is in Chinese adults who have undergone hematopoietic stem cell or organ transplantation and have a cytomegalovirus CMV infection and how well they tolerate treatment with maribavir Other aims are to see how effective maribavir is in treating CMV infection and getting rid of the symptoms the recurrence rate of CMV infection after treatment with maribavir and if the treatment is required again Researchers will also check for changes mutations occurring in the virus which may cause treatment with maribavir to no longer work well or to not work at all resistance to maribavir
The participants will be treated with maribavir for 8 weeks
During the study participants will visit their study clinic 18 times
The participants will be treated with maribavir for 8 weeks
During the study participants will visit their study clinic 18 times
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None