E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
GvHD prophylaxis with ATG-Fresenius S in allogenic Stem Cell Transplantation from matched unrelated donors |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018651 |
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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 |
Valutare l'efficacia di ATG-Fresenius S in aggiunta alla terapia standard (ciclosporina A/Metotressato) nel trattamento del fallimento precoce della terapia definito come il verificarsi della malattia del trapianto verso l'ospite di grado severo e acuta (grado III o IV) o di mortalita' precoce nei 100 giorni successivi al trapianto rispetto alla sola terapia standard.
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E.2.2 | Secondary objectives of the trial |
Confrontare i due bracci di trattamento (terapia standard associata ad ATC Fresenius e terapia standard) rispetto ai seguenti parametri: -periodo di tempo per il verificarsi della malattia del trapiando verso l'ospite acuta (grado I-IV, II-IV, III-IV) -incidenza e severita' delle infezioni fino al giorno +100 -periodo di tempo al trapianto -incidenza di malattia del trapianto verso l'ospite cronica (limitata ed estesa, estesa) nel tempo -sopravvivenza in assenza di malattia -incidenza di recrudescenze nel tempo -sopravvivenza in generale -sicurezza e tollerabilita' |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | |
E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
Primario: fallimento della terapia precoce definito come il verificarsi della malattia del trapianto verso l'ospite di grado severo e acuta (grado III o IV) o di mortalita' precoce nei 100 giorni successivi al trapianto. Secondari: -periodo di tempo per il verificarsi della malattia del trapiando verso l'ospite acuta (grado I-IV, II-IV, III-IV) -incidenza e severita' delle infezioni fino al giorno +100 -periodo di tempo al trapianto -incidenza di malattia del trapianto verso l'ospite cronica (limitata ed estesa, estesa) nel tempo -sopravvivenza in assenza di malattia -incidenza di recrudescenze nel tempo -sopravvivenza in generale -sicurezza e tollerabilita' |
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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 | Yes |
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 | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions 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.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |