Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237452
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-01-23
Brief Title:
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Sponsor:
Vedanta Biosciences Inc
Organization:
Vedanta Biosciences Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Status:
RECRUITING
Status Verified Date:
2024-09
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:
RESTORATiVE303
Brief Summary:
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection CDI recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo The objectives and endpoints are identical for Stage 1 recurrent CDI and Stage 2 high-risk primary CDI
Detailed Description:
None
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