E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Como terapia coadyuvante en la hiperamoniemia,el tratamiento con rifaximina elimina la traslocacion bacteriana y disminuye la respuesta inflamatoria sistémica, lo que condiciona un descenso de la actividad glutaminasa y reducción del amonio.lo que conllevaría a una menor producción intestinal de amonio y la desaparación de la EHM. |
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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 |
Valorar la eficacia terapéutica de la rifaximina frente a placebo en los pacientes con EHM. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Pacientes con cirrosis hepática, EHM y test de glutamina oral alterado, entre 18 - 75 años de edad, valorados y seguidos en la consulta externa de hepatología del Hospital Universitario de Valme. El diagnóstico de cirrosis se basa en criterios clínico-ecográficos-endoscópicos o mediante biopsia hepática. Los diagnósticos clínicos son la presencia de estigmas de hepatopatía junto a índices bioquímicos de descompensación de enfermedad hepática (albúmina sérica baja, TP prolongado, plaquetopenia). Los signos endoscópicos o ecográficos de hipertensión portal (HTP) o historia de episodios de descompensación (ascitis, ictericia, HDA por varices esofágicas. Clasificándolos respecto a la etiología y calculando el estadio de Child-Pugh y la puntuación de MELD.
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E.4 | Principal exclusion criteria |
Presencia de enfermedad sistémica grave (EPOC con P02 <60 mm Hg. o PCO>50 mm Hg.; insuficiencia renal con creatinina >2mg/dl, cardiopatía con NYHA >I), AVC u otra enfermedad neurológica, historia psiquiátrica, abuso de psicotropos en los 3 meses previo al estudio, derivación porto-cava y alcoholismo activo (abstinencia de 3 meses). Se investiga el consumo diario de alcohol en gramos y los años de duración de éste.
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E.5 End points |
E.5.1 | Primary end point(s) |
Encefalopatía hepática minima: Test Psicométricos Test de Glutamina oral Estudio de la frecuencia crítica del paparpadeo ADN bacteriano Cuestionario de perfil de impacto de la enfermedad |
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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 | Information not present in EudraCT |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
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.8.5 | 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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Cuando el último paciente incluido en el estudio termine el tratamiento segundo tras periodo de lavado. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |