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| Name | Class |
|---|---|
| JSS Medical Research Inc. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early treatment of fungal infections in participants who are refractory to, intolerant to, or medically precluded from first-line monotherapy or first-line combination antifungal therapy.
In the past two decades, invasive fungal infections (IFI) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with IFI. Over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. This has demonstrated the need for the development of a new generation of azoles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole | Experimental | Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole | Drug | Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment | Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ≥50% Decrease in Lesion Size or Number | Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study was conducted in 8 medical centers across Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Posaconazole | Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Posaconazole | Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment | Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. | The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment. | Posted | Number | Percentage of participants | Up to 6 months |
|
Up to 12 months
The Safety Population included all enrolled participants who received at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Posaconazole | Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Version 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Version 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Globalo Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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|
| Percentage of Participants With a CR or PR by 12 Weeks |
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. |
| Up to 12 Weeks |
| Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks | Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. | Up to 26 weeks |
| Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug | Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection. | Up to 6 months |
| Overall Survival at 3 Months | Total number of participant survivors was assessed at 3 months. | 3 months |
| Number of Participants With Response to Posaconazole in Combination Therapy | Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. | Up to 6 months |
| Number of Participants Experiencing Adverse Events (AEs) | An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. | Up to 12 months |
| Lost to Follow-up |
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| Palliative care |
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| Adverse Event |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With ≥50% Decrease in Lesion Size or Number | Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease. | This outcome measure was not reported as the Safety and Steering Committee (SSC) no longer considered it relevant based on revised Mycoses Study Group and European Organization for Research and Treatment of Cancer (MSG/EORTC) Consensus Criteria. | Posted | Up to 6 months |
|
|
| Secondary | Percentage of Participants With a CR or PR by 12 Weeks | Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. | The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment. | Posted | Number | Percentage of participants | Up to 12 Weeks |
|
|
|
| Secondary | Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks | Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. | The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment. | Posted | Number | Percentage of Participants | Up to 26 weeks |
|
|
|
| Secondary | Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug | Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection. | The Efficacy Population included those participants with a visit 6 months after the last dose. | Posted | Number | Percentage of participants | Up to 6 months |
|
|
|
| Secondary | Overall Survival at 3 Months | Total number of participant survivors was assessed at 3 months. | All enrolled participants | Posted | Number | Percentage of Participants | 3 months |
|
|
|
| Secondary | Number of Participants With Response to Posaconazole in Combination Therapy | Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. | The proportion of participants with response to posaconzole who received a prior combination antifungal regimen is not reported as per recommendation from the Safety and Steering Committee since only 1 participant was evaluable for this outcome measure. | Posted | Up to 6 months |
|
|
| Secondary | Number of Participants Experiencing Adverse Events (AEs) | An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. | All enrolled participants who received at least one dose of study medication. | Posted | Number | Number of participants | Up to 12 months |
|
|
|
| 16 |
| 40 |
| 35 |
| 40 |
| Cardiomyopathy | Cardiac disorders | Version 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Version 12.1 | Systematic Assessment |
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| Chills | General disorders | Version 12.1 | Systematic Assessment |
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| Generalised oedema | General disorders | Version 12.1 | Systematic Assessment |
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| Pyrexia | General disorders | Version 12.1 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Ludwig angina | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Lung infection pseudomonal | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Streptococcal sepsis | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | Version 12.1 | Systematic Assessment |
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| Liver function test abnormal | Investigations | Version 12.1 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | Version 12.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Version 12.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Version 12.1 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Version 12.1 | Systematic Assessment |
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| Neurotoxicity | Nervous system disorders | Version 12.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | Version 12.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Pulmonary cavitation | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Version 12.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Version 12.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Version 12.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Version 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Version 12.1 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | Version 12.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Version 12.1 | Systematic Assessment |
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| Chest pain | General disorders | Version 12.1 | Systematic Assessment |
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| Disease progression | General disorders | Version 12.1 | Systematic Assessment |
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| Fatigue | General disorders | Version 12.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | Version 12.1 | Systematic Assessment |
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| Pain | General disorders | Version 12.1 | Systematic Assessment |
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| Pyrexia | General disorders | Version 12.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Version 12.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Version 12.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Version 12.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Version 12.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | Version 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | Version 12.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Version 12.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Version 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | Version 12.1 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | Version 12.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Version 12.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | Version 12.1 | Systematic Assessment |
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| Thrombosis | Vascular disorders | Version 12.1 | Systematic Assessment |
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The Principal Investigators agree to provide review copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the protocol study to the sponsor, 30 days prior to submission for publication or presentation. The sponsor shall have the right to review and comment on the data analysis and presentation with regard to proprietary information and the accuracy of the information contained in the publication.
| Title | Measurements |
|---|---|
|
| Week 26, PR |
|