Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
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| ClinicalTrials.gov Identifier: NCT05238116 |
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Recruitment Status :
Recruiting
First Posted : February 14, 2022
Last Update Posted : March 18, 2024
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Sponsor:
Pulmocide Ltd
Information provided by (Responsible Party):
Pulmocide Ltd
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Brief Summary:
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Refractory IPA | Drug: PC945 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 123 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double Blind |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | June 14, 2022 |
| Estimated Primary Completion Date : | March 31, 2025 |
| Estimated Study Completion Date : | April 30, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Aspergillosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: PC945
PC945 dose, administered via nebulizer, twice daily
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Drug: PC945
Sterile aqueous liquid for Nebulization |
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Placebo Comparator: Placebo
PC945-placebo administered via nebulizer, twice daily
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Drug: Placebo
Sterile aqueous liquid for Nebulization |
Primary Outcome Measures :
- Number of Participants with Complete or Partial Overall Response [ Time Frame: up to 12 weeks (Day 84) ]
Secondary Outcome Measures :
- Time to Complete or Partial Overall Clinical Response [ Time Frame: up to 12 weeks (Day 84) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
- Participant's IPA has failed to respond to adequate antifungal therapy.
Exclusion Criteria:
- Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study.
- Participant who has previously received PC945.
- Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
- Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05238116
Contacts
| Contact: Chief Medical Officer | +44 (0)203 763 9484 | admin@pulmocide.com | |
| Contact: Vice President of Clinical Development | is +44 (0) 203 763 9484 | admin@pulmocide.com |
Locations
Show 76 study locations
Sponsors and Collaborators
Pulmocide Ltd
| Responsible Party: | Pulmocide Ltd |
| ClinicalTrials.gov Identifier: | NCT05238116 |
| Other Study ID Numbers: |
PC_ASP_006 2021-004554-32 ( EudraCT Number ) 2024-511281-36 ( Registry Identifier: EU CT Number ) |
| First Posted: | February 14, 2022 Key Record Dates |
| Last Update Posted: | March 18, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pulmocide Ltd:
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Refractory IPA invasive pulmonary aspergillosis |
Additional relevant MeSH terms:
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Aspergillosis Pulmonary Aspergillosis Invasive Pulmonary Aspergillosis Mycoses Bacterial Infections and Mycoses |
Infections Lung Diseases, Fungal Lung Diseases Respiratory Tract Diseases Invasive Fungal Infections |