E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients diagnosed as ‘invasive aspergillosis’, ‘serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of, or refractory to, other therapy’ or ‘candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds’ who have received Vfend IV will be included in the study. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to determine the problems and questions of following clauses on Vfend IV(voriconazole) 200 mg.
- unknown adverse event (especially, occurrence of serious adverse events)
- grasping the circumstantial factor of adverse event appearing under after maintained certain drug administrative pattern.
- factors affecting safety
- factors affecting efficacy
- etc.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients diagnosed as ‘invasive aspergillosis’, ‘serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of, or refractory to, other therapy’ or ‘candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds’ who have received Vfend IV will be included in the study. |
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E.4 | Principal exclusion criteria |
Vfend® is contraindicated in the following patients:
- Patients with known hypersensitivity to voriconazole or to any of the excipients.
- Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine with voriconazole : Increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes.
- Coadministration of voriconazole with rifampicin, carbamazepine and Phenobarbital: These medicinal products are likely to decrease plasma voriconazole concentrations significantly.
- Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates : Increased plasma concentrations of these medicinal products can lead to ergotism.
- Coadministration of voriconazole and sirolimus: Voriconazole is likely to increase plasma concentrations of sirolimus significantly.
- Coadministration of voriconazole with high-dose ritonavir (400 mg and above twice daily) is contraindicated because ritonavir significantly decreased plasma voriconazole concentrations in healthy subjects at this dose.
- Coadministration of voriconazole with efavirenz : Efavirenz significantly decreased voriconazole plasma concentrations while voriconazole also significantly increased efavirenz plasma concentrations.
- Coadministration of voriconazole with St John’s Wort is contraindicated.
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline (Day 1) up to 2 years |
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E.5.2 | Secondary end point(s) |
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (Day 1) up to 2 years |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |