Trial · NCT04218851
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) | Up to 14 days after treatment (up to Day 102) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson. |
| Secondary | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | Up to week 6 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. |
| Secondary | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | Up to Week 12 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. |
| Secondary | Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response | Up to 28 days post-treatment (up to Day 116) | In participants who achieved favorable global clinical response, relapse of IA is defined as the re-emergence of clinical, radiographic, or other relevant abnormalities indicating IA. |
| Secondary | Average Plasma Concentration (Cavg) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Cavg was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cavg parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Minimum Plasma Concentration (Cmin) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Cmin was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmin parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Maximum Plasma Concentration (Cmax) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Cmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmax parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state AUCtau was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 AUCtau parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Time to Reach Cmax (Tmax) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Tmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Tmax parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Average Plasma Concentration (Cavg) of POS by Formulation | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady-state Cavg was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2. |
| Secondary | Minimum Plasma Concentration (Cmin) of POS by Formulation | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady-state Cmin was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2. |
| Secondary | Maximum Plasma Concentration (Cmax) of POS by Formulation | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady-state Cmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2. |
| Secondary | Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady-state AUCtau was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2. |
| Secondary | Time to Reach Cmax (Tmax) of POS by Formulation | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady-state Tmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2. |
| Secondary | Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation | First day of PFS treatment (Day 8) | Palatability was categorized on the first day (Day 8) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group. Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad. |
| Secondary | Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation | Last day of PFS treatment (Day 85) | Palatability was categorized on the last day (Day 85) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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