Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
NCT05541107 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2022-09-15
Summary
This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).
Conditions
- Cryptococcal Meningitis
Interventions
- DRUG
-
MAT2203
oral lipid nanocrystal amphotericin B
- DRUG
-
Amphotericin B
Intravenous Amphotericin B
Sponsors & Collaborators
- collaborator OTHER
-
Matinas BioPharma Nanotechnologies, Inc.
lead INDUSTRY
Principal Investigators
-
David R Boulware, MD · University of Minnesota
-
David B Meya, MBChB · Infectious Diseases Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-31
- Primary Completion
- 2024-10-31
- Completion
- 2025-01-31
- FDA Drug
- Yes
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