Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05541107
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-15
First Post:
2022-09-12
Brief Title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
Sponsor:
Matinas BioPharma Nanotechnologies Inc
Organization:
Matinas BioPharma Nanotechnologies Inc
Study Overview
Official Title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-09
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:
EnACT3
Brief Summary:
This pivotal confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial MB-70007
Detailed Description:
Pivotal prospective randomized open-label non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy Randomization will by 111 to one of two experimental arms or standard of care
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTA 0217 | OTHER | Uganda National Drug Authority NDA | None |