E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ENFERMEDAD INJERTO CONTRA HUESPED |
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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 |
PROPORCION DE PACIENTES CON RESPUESTA CLINICA AL TRATAMIENTO, ENTENDIDA COMO RESPUESTA COMPLETA, PARCIAL O NO PROGRESION (ESTA ULTIMA SOLAMENTE EN ECIH CRONICO) DE AL MENOS 7 DIAS DE DURACION QUE SE OBSERVE EN EL PERIODO COMPRENDIDO DESDE LA PRIMERA INFUSION DE CME HASTA 45 DIAS DESPUES DE LA ULTIMA INFUSION |
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E.2.2 | Secondary objectives of the trial |
1) PROMEDIO DEL TIEMPO HASTA RESPUESTA CLINICA 2) INCIDENCIA Y DESCRIPCION PORCENTUAL DE LOS TIPOS DE ACONTECIMIENTOS ADVERSOS 3) COMPARAR EVOLUCION CLINICA POSTRASPLANTE (CURVA DE SUPERVIVENCIA GLOBAL, CURVA DE SUPERVIVENCIA LIBRE DE PROGRESION E INCIDENCIA ACUMULADA DE RECAIDAS) CON UNA COHORTE HISTÓRICA DEL MISMO CENTRO 4) EVOLUCION DEL RECUENTO ABSOLUTO Y PORCENTUAL DE LAS SUBPOBLACIONES LINFOCITARIAS EN SANGRE PERIFERICA, EN LOS DÍAS 0, 6, 13 Y 20 DE LA PRIMERA INFUSION DE CME 5) EVOLUCION DE LA PROPORCION DE QUIMERISMO HEMATOPOYÉTICO EN SANGRE PERIFERICA TRAS LA INFUSION DE CME, EN LOS DIAS 0, 6, 13 Y 20 DESDE LA PRIMERA INFUSION 6) PROMEDIO DEL TIEMPO EN DÍAS DESDE LA PRIMERA INFUSION DE CME HASTA EL COMIENZO DE BAJADA EN LA DOSIS DE ESTEROIDES 7) PROPORCION DE PACIENTES CON EICH AGUDO A LA INCLUSION QUE DESARROLLAN CRITERIOS DE EICH CRONICO A LO LARGO DEL PERIODO DE SEGUIMIENTO |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
PACIENTES CON EICH AGUDA RESISTENTES A ESTEROIDES (2 MG/KG/DÍA DE METILPREDNISOLONA) O EICH CRONICA EXTENSA SIN RESPUESTA A ESTEROIDES (2MG/KG/DIA DE METILPREDNISOLONA) E INMUNOMODULADORES HABITUALES (INCLUYE MICOFENOLATO MOFETIL Y ANTAGONISTAS DE LA CALCINEURINA A CUALQUIER DOSIS) |
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E.4 | Principal exclusion criteria |
PACIENTES QUE NO OTORGUEN CONSENTIMIENTO INFORMADO INFECCION ACTIVA GRAVE EN EL MOMENTO DE LA INCLUSION ARRITMIA EN EL MOMENTO DE LA INCLUSION INSUFICIENCIA CARDIACA EN EL MOMENTO DE LA INCLUSION ENFERMEDAD DE BASE EN PROGRESION EN EL MOMENTO DE LA INCLUSION CUALQUIER ENFERMEDAD O SITUACION CLÍNICA NO RELACIONADA CON EL EICH QUE HAGA PREVER UNA SUPERVIVENCIA INFERIOR A UN MES EMBARAZO, LACTANCIA |
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E.5 End points |
E.5.1 | Primary end point(s) |
RESPUESTA CLINICA: - EN EICH AGUDO: RESPUESTA COMPLETA O RESPUESTA PARCIAL - EN EICH CRONICO: RESPUESTA COMPLETA, PARCIAL O NO PROGRESION |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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) | 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
| 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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |