E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prophylaxis for patients at high risk for invasive fungal diseases |
|
E.1.1.1 | Medical condition in easily understood language |
prevention of fungal infection |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017533 |
E.1.2 | Term | Fungal infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 determine the pharmacokinetics of micafungin 300 mg given twice weekly on Mondays and Thursdays in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for SCT; receiving first remission induction chemotherapy for AML/MDS) compared to the pharmacokinetics of micafungin 100 mg given daily to the same population. |
|
E.2.2 | Secondary objectives of the trial |
To determine whether adequate exposure of micafungin is attained and to perform Monte Carlo simulations to provide the scientific background for alternate dosing strategies in the prophylactic setting.
To determine the safety of micafungin in this patient population |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient receives immunosuppressive therapy for acuteGvHD grade II-IV or reduced in-tensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
2. Subject is at least 18 of age on the day of providing informed consent.
3. Has no signs or symptoms of invasive fungal disease
4. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
5. Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD
6. Is managed with a central venous catheter (preferably a quadruple Ar-row-Howes™ Quad-Lumen 8.5,5 French; Arrow International)
7. Subject is able and willing to sign the Informed Consent before screening evaluations. |
|
E.4 | Principal exclusion criteria |
1. Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation
2. History of or current abuse of drugs, alcohol or solvents.
3. Inability to understand the nature of the trial and the procedures re-quired.
4. Has not previously participated in this trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of PK parameters (AUC, Cmax) after both treatment regimens. |
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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) |
Monte Carlo simulations
testing of covariates influencing PK
adverse events during the study |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Monta Carlo simulations: PK curves on Day 4 or 5 and Day 8, trough concentrations every day.
Adverse events will be collected during the entire study period. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
once daily dosing group is the control group |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |