Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
NCT05238116 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2026-04-30
Summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Conditions
- Refractory IPA
Interventions
- DRUG
-
PC945
Sterile aqueous liquid for Nebulization
- DRUG
-
Sterile aqueous liquid for Nebulization
Sponsors & Collaborators
-
Pulmocide Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-14
- Primary Completion
- 2025-12-29
- Completion
- 2025-12-29
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Chile
- Colombia
- France
- Germany
- Greece
- India
- Israel
- Italy
- South Korea
- Spain
- Taiwan
- Thailand
- United Kingdom
Study Locations
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