Clinical Trials List
Protocol NumberPC_ASP_006
NCT Number(ClinicalTrials.gov Identfier)NCT05238116
2022-08-25 - 2026-01-31
Phase III
Recruiting5
ICD-10B44.1
Other pulmonary aspergillosis
ICD-10B44.2
Tonsillar aspergillosis
ICD-10B44.7
Disseminated aspergillosis
ICD-10B44.89
Other forms of aspergillosis
ICD-10B44.9
Aspergillosis, unspecified
ICD-10B48.4
Penicillosis
ICD-9117.3
Aspergillosis
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)
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- - - 無
- Huai-Hsuan Huang 無
- Chien-Chin Lin 無
- 陳抱宇 無
- HSIN-AN HOU 無
- BANG-BIN CHEN 無
- MING YAO 無
- 田豐銘 無
- CHAO-CHI HO CHAO-CHI HO 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yen-Hsu Chen 無
- Tun-Chieh Chen 無
- Ming-Ju Tsai 無
- Hui-Hua Hsiao 無
- Shang-Yi Lin 無
- Chun-Yuan Lee 無
- 張雅婷 無
- 鄭孟軒 無
- Shih-Feng Cho 無
- Chung-Hao Huang 無
- 蔡毓德 無
- 陳家閔 無
- Yi-Chang Liu 無
- 羅世豪 無
- Chau-Chyun Sheu 無
- Hung-Ling Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Refractory IPA
Objectives
Main Objectives
- To evaluate the efficacy of nebulized PC945 combined with systemic antifungal agents in the treatment of refractory, invasive pulmonary aspergillosis.
Secondary Objectives
- To evaluate the safety and tolerability of aerosolized PC945 in combination with systemic antifungal agents for the treatment of refractory, invasive pulmonary aspergillosis.
Pharmacokinetic goals
- To evaluate the pharmacokinetic (PK) properties of PC945 in plasma and lungs after single and multiple nebulized doses
Test Drug
PC945
Active Ingredient
opelconazole
Dosage Form
Liquid for a Nebulizer
Dosage
4.0 mg/ml
Endpoints
Main efficacy results
Good overall response at Day 84: Subject is alive and has a complete or partial overall response as assessed by the Data Review Committee (DRC) at Day 84.
Secondary Efficacy Outcomes
‧ Good overall response: having a good response at any time during the 12-week treatment period.
‧ Time to achieve good clinical remission: The time from the first dose of trial drug to the first good clinical remission for subjects who had a good overall remission at any time during the 12-week treatment period.
‧ Death from all causes
Exploratory Efficacy Results
‧ No progression: Subjects have a best complete response, partial response, or no change in disease condition
‧ DRC determined deaths due to IPA through a complete safety follow-up period
‧ Good overall response at day 42
‧ Subjects who did not achieve complete remission or partial remission during the treatment period (baseline to day 84) had good overall remission during the safety follow-up period (days 85 to 112)
Components of overall response (clinical response, mycological response, radiographic response) at Days 42 and 84, and during safety follow-up until Day 112
‧ Use of rescue mycotic active therapy throughout the 12-week treatment period
‧ Subjects who had a good overall response during the 12-week treatment period and had an IPA relapse at any time during the trial
Safety and Tolerability Results
‧ Adverse events, changes in vital signs, laboratory data and electrocardiogram (ECG)
‧ Adverse events of special concern:
‧ Adverse events associated with inhaled investigational drugs, such as bronchospasm, hypersensitivity pneumonitis, local effects of the drug
(i.e. cough, dysphonia, upper respiratory tract irritation, etc.)
‧ Mean forced expiratory volume in 1 second (FEV1) decreased by >= 15% between pre- and post-dose of the trial drug
‧ Changes in lung function on days 84 and 112, using spirometry data (FEV1, forced vital capacity (FVC), percent predicted FEV1, and percent predicted FVC)
‧ Adverse events leading to temporary (at least one dose) or permanent discontinuation of the trial drug
‧ Dose adjustment of investigational drug
‧ Drug interactions
Pharmacokinetic evaluation
‧ Maximum concentration (Cmax)
‧ Time to reach maximum concentration (Cmax)
‧ Minimum concentration at the end of the dosing interval (Ctrough)
‧ Total area under the concentration curve from before dosing (time 0) to the end of the dosing interval (AUC0-τ)
‧ Total area under the concentration curve at steady state (Ctrough x dosing interval)
‧ Drug accumulation ratio (Ro)
‧ Clearance ratio (CL/F)
‧ Estimated half-life (t1/2)
PC945 concentrations in the lung were measured using pelleted cells and epithelial cell linings obtained by bronchoalveolar lavage (BAL).
(ELF), and (when tissue samples are available) bronchial brushings or endobronchial or transbronchial sections, will include:
‧ PC945 lung concentration: plasma concentration ratio
Good overall response at Day 84: Subject is alive and has a complete or partial overall response as assessed by the Data Review Committee (DRC) at Day 84.
Secondary Efficacy Outcomes
‧ Good overall response: having a good response at any time during the 12-week treatment period.
‧ Time to achieve good clinical remission: The time from the first dose of trial drug to the first good clinical remission for subjects who had a good overall remission at any time during the 12-week treatment period.
‧ Death from all causes
Exploratory Efficacy Results
‧ No progression: Subjects have a best complete response, partial response, or no change in disease condition
‧ DRC determined deaths due to IPA through a complete safety follow-up period
‧ Good overall response at day 42
‧ Subjects who did not achieve complete remission or partial remission during the treatment period (baseline to day 84) had good overall remission during the safety follow-up period (days 85 to 112)
Components of overall response (clinical response, mycological response, radiographic response) at Days 42 and 84, and during safety follow-up until Day 112
‧ Use of rescue mycotic active therapy throughout the 12-week treatment period
‧ Subjects who had a good overall response during the 12-week treatment period and had an IPA relapse at any time during the trial
Safety and Tolerability Results
‧ Adverse events, changes in vital signs, laboratory data and electrocardiogram (ECG)
‧ Adverse events of special concern:
‧ Adverse events associated with inhaled investigational drugs, such as bronchospasm, hypersensitivity pneumonitis, local effects of the drug
(i.e. cough, dysphonia, upper respiratory tract irritation, etc.)
‧ Mean forced expiratory volume in 1 second (FEV1) decreased by >= 15% between pre- and post-dose of the trial drug
‧ Changes in lung function on days 84 and 112, using spirometry data (FEV1, forced vital capacity (FVC), percent predicted FEV1, and percent predicted FVC)
‧ Adverse events leading to temporary (at least one dose) or permanent discontinuation of the trial drug
‧ Dose adjustment of investigational drug
‧ Drug interactions
Pharmacokinetic evaluation
‧ Maximum concentration (Cmax)
‧ Time to reach maximum concentration (Cmax)
‧ Minimum concentration at the end of the dosing interval (Ctrough)
‧ Total area under the concentration curve from before dosing (time 0) to the end of the dosing interval (AUC0-τ)
‧ Total area under the concentration curve at steady state (Ctrough x dosing interval)
‧ Drug accumulation ratio (Ro)
‧ Clearance ratio (CL/F)
‧ Estimated half-life (t1/2)
PC945 concentrations in the lung were measured using pelleted cells and epithelial cell linings obtained by bronchoalveolar lavage (BAL).
(ELF), and (when tissue samples are available) bronchial brushings or endobronchial or transbronchial sections, will include:
‧ PC945 lung concentration: plasma concentration ratio
Inclution 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.
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
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
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
The Estimated Number of Participants
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Taiwan
6 participants
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Global
123 participants
