E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Candida or Aspergillus Infections |
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E.1.1.1 | Medical condition in easily understood language |
Treatment of Fungal Infections |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 |
To evaluate the safety and tolerability of caspofungin in Japanese pediatric patients. |
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E.2.2 | Secondary objectives of the trial |
(1) To evaluate the proportion of Japanese pediatric patients with a favorable efficacy response (based on overall response) to caspofungin therapy in each of the different infection types (invasive candidiasis, esophageal candidiasis, and aspergillosis).
(2)To evaluate caspofungin plasma concentration profiles and pharmacokinetic parameters obtained in Japanese pediatric patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female Japanese patient between the ages of 3 months and 17 years at the time when informed consent was obtained.
• Patients in whom a causative fungus was detected before treatment with the study drug or patients with strongly suspected Candida or Aspergillus infections, as defined below for esophageal candidiasis, invasive candidiasis (candidemia or other types of invasive candidiasis), and aspergillosis (invasive aspergillosis, chronic necrotizing pulmonary aspergillosis, or pulmonary aspergilloma).
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E.4 | Principal exclusion criteria |
• Patients with mycoses (e.g., Cryptococcus spp., Trichosporon spp., or zygomycetes including Mucor spp.) other than ones due to Candida spp. or Aspergillus spp.
• Patients who will receive other systemic antifungal agents (indicated for deep-seated fungal infections) for the first time in the screening period.
• At screening, patients with any of the laboratory abnormalities listed below: (1) Total bilirubin: More than 5 times the upper limit of the normal range (>5 ULN), (2) AST (SGOT) or ALT (SGPT): More than 5 times the upper limit of the normal range (>5 ULN)
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluate the safety and tolerability of caspofungin in Japanese pediatric patients. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Evaluate the proportion of Japanese pediatric patients with a favorable efficacy response to caspofungin therapy in each of the different infection types |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |