Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706923
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-01-05
Brief Title:
A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
Sponsor:
SymBio Pharmaceuticals
Organization:
SymBio Pharmaceuticals
Study Overview
Official Title:
A Phase IIa Open-label Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ATHENA
Brief Summary:
The purpose of this study is to determine the safety and tolerability of intravenous IV brincidofovir BCV SyB V-1901 02 mgkg 03 mgkg or 04 mgkg dosed twice weekly BIW or 04 mgkg dosed once weekly QW for 4 weeks in subjects with AdV and IV BCV in subjects with CMV
Detailed Description:
This is a Phase IIa open-label multiple ascending dose confirmation multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir BCV SyB V-1901 02 mgkg 03 mgkg or 04 mgkg dosed BIW or 04 mgkg dosed QW Cohorts 1 to 4 in adult and pediatric subjects with AdV viremia and IV BCV in subjects with CMV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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