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NCT05238116 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
A Phase 3 study, sponsored by Pulmocide.
- Terminated
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
NCT05238116: Clinical Trial Phase 3 study, sponsored by Pulmocide.
NCT05238116 is a Phase 3 study that was terminated before completion, run by Pulmocide. The registered enrollment target is 85 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05238116, a Phase 3 study, was terminated before completion, sponsored by Pulmocide.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
Study Summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Primary Outcome
Favorable overall response was defined as being alive and having a complete or partial overall response at Day 84 as determined by the DRC. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Interventions
- DRUG Placebo
- DRUG PC945
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2025-12-29 |
| Phase | Phase 3 |
Why NCT05238116 stopped before completion
NCT05238116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05238116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05238116 about?
NCT05238116 is a clinical study titled "Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)". To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
What is the current status of trial NCT05238116?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2022-06-14. Estimated completion is 2025-12-29.
What interventions are being tested in trial NCT05238116?
The interventions under investigation include: Placebo (DRUG), PC945 (DRUG).
Who is sponsoring clinical trial NCT05238116?
This trial is sponsored by Pulmocide, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05238116's enrollment target sits among peer trials
85 1747th of 2000 higher than 252 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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