E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024667 |
E.1.2 | Term | Liver cirrhosis |
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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 |
Estudio farmacodinámico de carácter fisiopatológico que evaluará los efectos de la administración prolongada de albúmina humana sobre la función cardiocirculatoria y renal y la hemodinámica hepática en pacientes con cirrosis avanzada y ascitis |
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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 |
- Edad superior a 18 años e inferior a 80 años. - Diagnóstico de cirrosis hepática establecido por biopsia o por datos clínicos, analíticos y ecográficos. - Requerimientos diarios de diuréticos: al menos 200mg de espironolactona o 100mg de espironolactona y 40 mg de furosemida. - Disfunción renal definida por una concentración plasmática de creatinina sérica ≥ 1,2 mg/dl, BUN ≥ 25 mg/dl, o una concentración plasmática de sodio ≤ 130 mEq/L.
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E.4 | Principal exclusion criteria |
- Ascitis refractaria (requerimientos de paracentesis evacuadoras superiores a 1 por mes). - Tratamiento con fármacos beta-bloqueantes. - Enfermedad neoplásica incluyendo el hepatocarcinoma si supera los criterios de Milan (un nódulo > 5cm o tres nodulos > 3 cm). - Antecedentes de TIPS o shunt quirúrgico. - Infección bacteriana o hemorragia digestiva documentada en los últimos 15 días. - Insuficiencia cardiaca o cardiopatía estructural. - Insuficiencia renal orgánica (proteinuria, hematuria y/o datos ecográficos de nefropatía). - Enfermedad pulmonar crónica moderada o grave. - Trasplante previo. - Infección por el virus de inmunodeficiencia humana. - Adicción activa a drogas. - Estado mental que impida al paciente entender la naturaleza, alcance y consecuencias del estudio, a excepción de la encefalopatía hepática. - Embarazo.
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E.5 End points |
E.5.1 | Primary end point(s) |
Actividad de la renina plasmática y concentración plasmática de noradrenalina, filtrado glomerular, hipertensión portal y función cardiaca. |
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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 | 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 | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |