E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cirrosis con signos de hipertensión portal significativa |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019641 |
E.1.2 | Term | Cirrosis hepática |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036200 |
E.1.2 | Term | Hipertensión portal |
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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 |
1. Evaluar la seguridad y tolerancia de Octreolin (formulación de octreotida oral) en sujetos con cirrosis e hipertensión portal 2. Evaluar el efecto de Octreolin sobre el gradiente de presión venosa hepática (GPVH) en sujetos con cirrosis e hipertensión portal 3. Evaluar el perfil farmacocinético (PK) de Octreolin en sujetos con cirrosis e hipertensión portal tras una única administración |
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E.2.2 | Secondary objectives of the trial |
1. Seleccionar la dosis eficaz de Octreolin en sujetos con cirrosis e hipertensión portal 2. Evaluar el efecto de Octreolin sobre el GPVH en sujetos tratados actualmente con beta-bloqueantes no selectivos (NSBB) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Sujetos con cirrosis hepática estable (diagnosticada mediante biopsia o mediante datos de obtención de imágenes y de laboratorio, clínicos inequívocos) remitidos para la medición de GPVH -Presencia de varices esofágicas (cualquier grado) -GPVH 12 mmHg durante el estudio hemodinámico -Medicación: diuréticos convencionales y NSBB permitidos si se han tomado durante más de 6 semanas en una dosis estable |
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E.4 | Principal exclusion criteria |
-Complicaciones agudas de hipertensión portal en las 6 semanas previas a la inclusión (hemorragias a causa de varices, síndrome hepatorrenal, septicemia o peritonitis bacteriana espontánea, encefalopatía hepática, ascitis tensa que requiere paracentesis) -Carcinoma hepatocelular fuera de los criterios de Milán -Insuficiencia hepática avanzada, con una razón de protrombina <35% y bilirrubina > 6 mg/dL, y recuento de plaquetas < 40.000 -Oclusión mediante trombosis del tronco de la vena porta -Insuficiencia cardiaca, renal o respiratoria que en opinión del investigador puede aumentar significativamente el riesgo del bienestar del sujeto -Derivación quirúrgica previa o derivaciones transyugulares intrahepáticas portosistémicas -Hipertensión pulmonar |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Determinar el efecto de Octreolin sobre la respuesta de GPVH 2.Evaluar si la magnitud del cambio de GPVH es similar en sujetos que reciben NSBB y sujetos que no reciben terapia crónica para la hipertensión portal tras la administración de dos dosis orales diferentes de Octreolin 3.Evaluar la PK de una administración oral única de Octreolin en esta población 4.Seguridad y tolerancia |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |