Trials / Terminated
TerminatedNCT05238116
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Pulmocide Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PC945 | Sterile aqueous liquid for Nebulization |
| DRUG | Placebo | Sterile aqueous liquid for Nebulization |
Timeline
- Start date
- 2022-06-14
- Primary completion
- 2025-12-29
- Completion
- 2025-12-29
- First posted
- 2022-02-14
- Last updated
- 2026-01-15
Locations
83 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, Greece, India, Israel, Italy, South Korea, Spain, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05238116. Inclusion in this directory is not an endorsement.