E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Plasma concentrations of colloidal Amphotericin B will be measured in critically ill Patients with hepatic impairment and with normal liver function, both requiring treatment with Amphocil, to determine the effect of liver impairment on the pharmacokinetics of colloidal Amphotericin B |
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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 determine plasma concentrations of colloidal Amphotericin B in critically ill patients with liver impairment compared to critically ill patients with normal liver function |
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E.2.2 | Secondary objectives of the trial |
to detect an effect of liver impairment on the pharmacokinetics of colloidal amphotericin b |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Indication for treatment with Amphocil (colloidal Amphotericin B) • proven or probable invasiv mycosis • renal insufficiency at the begin of therapy (serum-Creatinin > 1,5 mg/dl and under renal replacement therapy, respectively) • Aggravation of the renal function under the treatment with Amphotericin B deoxycholate • concomittant nephrotoxic medication (e.g. Aminoglykoside, Glycopeptide or Cyclosporin A) • Bilirubin < 1.28 mg/dl (Controlgroup), Bilirubin > 10 mg/dl (cholestatic liver failure) at the beginning of therapy with colloidal Amphotericin B • Bilirubin increase (> 10 mg/dl) by cholestatic liver failure under therapy with colloidal Amphotericin B (under steady-state)
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E.4 | Principal exclusion criteria |
• lacking indication/contraindication for colloidal Amphotericin B • Age < 18 Jahre • lacking consent • pregnancy • Bilirubin > 1.28 and < 10 mg/dl |
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E.5 End points |
E.5.1 | Primary end point(s) |
* Plasma concentrations of colloidal Amphotericin B in patients with hepatic impairment * Plasma concentrations of colloidal Amphotericin B in patients with normal liver function
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
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 |
patients with normal liver function |
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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 | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |