E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hepatic encephalopathty |
encefalopatía hepática |
|
E.1.1.1 | Medical condition in easily understood language |
hepatic encephalopathty |
encefalopatía hepática |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019642 |
E.1.2 | Term | Hepatic cirrhosis NOS |
E.1.2 | System Organ Class | 100000004871 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019660 |
E.1.2 | Term | Hepatic encephalopathy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 assess whether albumin administration after an episode of hepatic encephalopathy improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation). |
Evaluar si la administración de albúmina después de un episodio de EH mejora la supervivencia a los 90 días (La variable mortalidad se tratará como una variable combinada mortalidad y/o trasplante hepático). |
|
E.2.2 | Secondary objectives of the trial |
-To evaluate whether albumin administration after an episode of hepatic encephalopathy improves survival at 30, 90 and 180 days. - to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. - To analyze whether albumin administration reduces hospitalization requirement. - To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones). - Establishing a serum bank for biochemical and genetic studies related to the pathophysiology of hepatic encephalopathy. |
-Evaluar si la administración de albúmina después de un episodio de EH mejora la supervivencia a los 30, 90 y 180 días. - Evaluar los efectos de la albúmina sobre la recidiva de la encefalopatía hepática durante todo el periodo el estudio. - Analizar si la administración de albúmina disminuye el requerimiento de hospitalizaciones. -Estudiar los efectos de la albúmina sobre índices de disfunción circulatoria (presión arterial media, función renal, concentración plasmática de hormonas vasopresoras). - Constituir una seroteca para estudios bioquímicos y genéticos en relación a la fisiopatología de la encefalopatía hepática. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age between 18 and 85 years. 2. Liver cirrhosis defined by previous clinical data or liver biopsy. 3. Presence of an episode of acute hepatic encephalopathy of grade> 2. 4. Sign the informed consent |
1. Edad entre 18 y 85 años. 2. Cirrosis hepática definida por una biopsia hepática previa o por datos clínicos. 3. Presencia de un episodio de encefalopatía hepática aguda de un grado >2. 4. Firmar el consentimiento informado |
|
E.4 | Principal exclusion criteria |
1. Pregnant or breast-feeding. 2. Terminal illness. 3. Presence of Acute-on-chronic liver failure. 4. Needing for intensive support measures. 5. Active gastrointestinal bleeding. 6. neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy. 7. Clinical situations in which it is contraindicated to administer intravenous albumin. 8. MELD score less than 15 or greater than 25 at the time of inclusion 9. Any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period. |
1. Mujeres embarazadas o en periodo de lactancia. 2. Enfermedad terminal. 3. Presencia de Acute-on-chronic liver failure. 4. Necesidad de medidas de soporte intensivo. 5. Hemorragia digestiva activa. 6. Comorbilidad neurológica o psiquiátrica que dificulte la valoración de la encefalopatía hepática. 7. Situaciones clínicas en las que esté contraindicado administrar albúmina endovenosa. 8. MELD score inferior a 15 o superior a 25 en el momento de la inclusión 9. Cualquier condición médica a la inclusión del paciente en el estudio que requiera de la administración de albúmina durante un período previo o anterior de 7 días. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation). |
Supervivencia a los 90 días. (La variable mortalidad se tratará como una variable combinada mortalidad y/o trasplante hepático). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- To evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. - To analyze whether albumin administration reduces hospitalization requirement. - Survival at 180 days. |
- Evaluar los efectos de la albúmina sobre la recidiva de la encefalopatía hepática durante todo el periodo el estudio. - Analizar si la administración de albúmina disminuye el requerimiento de hospitalizaciones. -Supervivencia a los 180 días. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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) | 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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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 | No |
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
|
LVLS |
Última visita del último paciente |
|
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 | |
E.8.9.2 | In all countries concerned by the trial years | 3 |