E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
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 primary objective is to demonstrate treatment efficacy of Certican® (everolimus) as add-on therapy against CMV-disease in comparison to either valganciclovir or ganciclovir alone, as measured by qCMV-PCR titers. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to demonstrate the efficacy of Certican® as add-on therapy against CMV-disease in comparison to either valganciclovir or ganciclovir alone and to assess the safety and the tolerability of Certican® in patients with CMV-disease. Moreover, to study the effects of Certican® treatment on the quality of life.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• CMV-disease after renal transplantation, i.e.(1.) CMV present in the blood, and (2.) one of the following symptoms (for viral syndrome, from the Amercan Society of Transplantation recommendations for use in clinical trials): body temperature ≥38°C, new or increased significant malaise, leucopenia (<3500/mL), atypical lymphocytosis ≥5%, thrombocytopaenia (platelets <100.000/mL) • informed consent of the patient
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E.4 | Principal exclusion criteria |
• acute rejection episodes in the first 3 months after renal transplantation • active hepatitis in the month prior • hematocrit <25% • any significant wound healing disorder • blood white blood cell (WBC) count <3000/mL • platelets <50.000/mL • severe dyslipidemia (cholesterol >300mg/dL, triglycerides >350mg/dL)) • uncontrolled hypertension • uncontrolled hyperuricemia • pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the lowering of CMV-titers, as determined by qCMV PCR, statistically analyzed by comparing the CMV-titer curves of the Certican® group versus the other (by ANOVA). |
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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 | 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) | 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 | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |